CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located in our King of Prussia PA office. It is a Hybrid role. You will report to the Director, Regional Regulatory TA Lead. RESPONSIBILITIES: You will be the primary CSL representative to regional health authorities for assigned products. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC) and team members to enhance these relationships. Contribute to regulatory and account for changes in relevant regulations / laws helping CSL's business within the Region North America and providing regulatory assessment of these changes. Assure a productive collaboration with important company partners, such as Regional commercial operations, to ensure successful development, strategic agreement and execution of regional regulatory strategies that result in successful applications for assigned products, from early development to Marketing Authorization (MA), and for any post MA submissions. You will contribute regional regulatory perspective to the global regulatory strategy and aligning regional strategies with the global strategy throughout the product lifecycle for assigned products. Guide. facilitate comprehensive, commercially and globally aligned regulatory activities within GRA NA for assigned products throughout development and after commercialization. Be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the delivery of science-based and globally aligned regulatory strategy with GRL. Your Experience A bachelor's degree in Science or Pharmacy. 7+ years of experience in the pharmaceutical industry in Biologics/Research & Development, some experience may be accounted for with advanced degree. 3+ years of experience in regulatory, supported by additional pharmaceutical /industry experience. Direct regulatory-facing experience Working knowledge of regulatory guidelines and legislative requirements for US FDA regulations. Experience in negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Driving complex projects throughout a product's lifecycle utilizing broad experience with health authorities or project teams Benefits Medical, Dental, Vision 401k PTO Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
04/18/2024
Full time
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located in our King of Prussia PA office. It is a Hybrid role. You will report to the Director, Regional Regulatory TA Lead. RESPONSIBILITIES: You will be the primary CSL representative to regional health authorities for assigned products. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC) and team members to enhance these relationships. Contribute to regulatory and account for changes in relevant regulations / laws helping CSL's business within the Region North America and providing regulatory assessment of these changes. Assure a productive collaboration with important company partners, such as Regional commercial operations, to ensure successful development, strategic agreement and execution of regional regulatory strategies that result in successful applications for assigned products, from early development to Marketing Authorization (MA), and for any post MA submissions. You will contribute regional regulatory perspective to the global regulatory strategy and aligning regional strategies with the global strategy throughout the product lifecycle for assigned products. Guide. facilitate comprehensive, commercially and globally aligned regulatory activities within GRA NA for assigned products throughout development and after commercialization. Be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the delivery of science-based and globally aligned regulatory strategy with GRL. Your Experience A bachelor's degree in Science or Pharmacy. 7+ years of experience in the pharmaceutical industry in Biologics/Research & Development, some experience may be accounted for with advanced degree. 3+ years of experience in regulatory, supported by additional pharmaceutical /industry experience. Direct regulatory-facing experience Working knowledge of regulatory guidelines and legislative requirements for US FDA regulations. Experience in negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Driving complex projects throughout a product's lifecycle utilizing broad experience with health authorities or project teams Benefits Medical, Dental, Vision 401k PTO Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Job SUMMARY: Allergan is looking for an experienced business leader with a demonstrated track record of developing high-performing teams, collaborating and influencing across matrixed organizations! The ideal candidate will have an exceptional ability to deeply understand the science and landscape, as well as the business considerations important to developing and implementing customer centric strategies. This role will require a leader who combines executive presence, emotional intelligence and a strong work ethic to develop a best-in-class strategic planning capability within the body contouring franchise. The Executive Director, reports to the Associate Vice President of Marketing, and is responsible for the development, analysis and refinement of the body contouring downstream strategies. The Executive Director, Body Contouring Professional Marketing is responsible for the HCP strategy development and commercialization of one of the most exciting launches in the body contouring industry. Responsibilities include, capital and consumable strategies to drive rapid adoption within the body contouring marketplace, pricing and value proposition strategy and consumer activation strategies to drive growth. A key imperative is to maximize the uptake at launch and ultimate value of the brand. This position works in close collaboration with cross functional groups to ensure a successful launch and growth in the core CoolSculpting business. Including sales, Allergan Data Labs, professional relations, finance, sales training, supply operations and GCD. This position works closely with the body contouring HCP community and will need to build strong relationships and gain product advocacy with KOLs, customers and prospects. Therefore, this individual should be highly collaborative, as they will be working with various internal customers and external partners, as well as getting buy-in from key stakeholders. The ideal candidate will have a solid track-record demonstrating strong business acumen, where s/he has successfully taken ideas from inception to completion. Supervisory responsibility: (if applicable) Lead and manage a team that is accountable for the professional strategies to drive system adoption and consumable growth for the Body Contouring division. KEY DUTIES AND RESPONSIBILITIES: Describe scope: % of Time or Importance Responsible for leading a comprehensive commercialization plan, developing HCP product positioning, core messages, growth strategy and annual marketing plan. Analyze competitive promotional activity and implement appropriate actions. Reviews and responds to changing market dynamics, as indicated through market analysis, customer interaction and sales input, to ensure achievement of goals by directing activities to a rapidly evolving landscape. Provide ongoing program leadership, supervise vendors and agencies and support field execution. Monitor and accelerate program performance through sales and ROI analysis. Contribute towards achieving brand financial and market share goals, manage promotional budget, deliver quarterly profit targets 40% Drive CoolSculpting commercial programs through a collaborative approach with sales and consumer marketing team (ADL) to develop and execute highly effective commercial impact with customers. These programs should incorporate KOL / advisory board feedback from customers. Responsible for overseeing management of all professional program related education, managing the commercial programs budget and external vendors to ensure efficient use of funds, ROI against set objectives and optimal customer service to our customers. 25% Oversee the development and management of promotional programs and tools: Lead the team to develop promotional tactics and sales tools that support brand strategies for capital equipment and consumable businesses. Collaborate with Regulatory, Medical, Legal, Compliance in development of all promotional pieces and programs. Effectively and collaboratively manage agency partners. Participate as appropriate in meetings with Global Commercial Development, Med Affairs, and International Brand teams. 20% Develops and maintains a customer focus that includes effective working relationships with KOL customers (HCP's and CS Specialists) in conjunction with strategy and campaign development. Provide sales team leadership and training, work with field sales representatives on a regular basis, support field training as needed, attend major conventions and meetings, educational and prospecting programs and events. 15% Qualifications job QUALIFICATIONS (MINIMUM REQUIREMENTS): Requirements: Minimum 15+ years of professional industry experience, including at least 3+ years in managerial positions at a medium-to-large health care company (device, phamra, OTC or FMCG). 5+ years professional/consumer marketing- Medical Device preferred but not mandatory. Knowledge of health care and/or Medical Device industry preferred (not mandatory). Solid knowledge of marketing areas including product positioning, marketing plan development and execution, strategic communications, product launch etc. Successful track record of strategic and tactical marketing. Experience launching Medical Devices preferred. Essential Skills, and Competencies: Proven leadership ability to work effectively and influences through others Financial/budgetary experience Ability to analyze difficult, complex situations, understand the details, and not get lost in them Ability to make difficult decisions, deal quickly and effectively with changes, and confront conflict constructively (strong resolution skills) Excellent communication skills, both oral and written, with an ability to make effective presentations to customers, sales team, and senior management Ability to appropriately prioritize and execute multiple critical issues Strong interpersonal skills, managing multiple stakeholders in a changing and flexible environment Willingness to travel 40% of the time Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/28/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Job SUMMARY: Allergan is looking for an experienced business leader with a demonstrated track record of developing high-performing teams, collaborating and influencing across matrixed organizations! The ideal candidate will have an exceptional ability to deeply understand the science and landscape, as well as the business considerations important to developing and implementing customer centric strategies. This role will require a leader who combines executive presence, emotional intelligence and a strong work ethic to develop a best-in-class strategic planning capability within the body contouring franchise. The Executive Director, reports to the Associate Vice President of Marketing, and is responsible for the development, analysis and refinement of the body contouring downstream strategies. The Executive Director, Body Contouring Professional Marketing is responsible for the HCP strategy development and commercialization of one of the most exciting launches in the body contouring industry. Responsibilities include, capital and consumable strategies to drive rapid adoption within the body contouring marketplace, pricing and value proposition strategy and consumer activation strategies to drive growth. A key imperative is to maximize the uptake at launch and ultimate value of the brand. This position works in close collaboration with cross functional groups to ensure a successful launch and growth in the core CoolSculpting business. Including sales, Allergan Data Labs, professional relations, finance, sales training, supply operations and GCD. This position works closely with the body contouring HCP community and will need to build strong relationships and gain product advocacy with KOLs, customers and prospects. Therefore, this individual should be highly collaborative, as they will be working with various internal customers and external partners, as well as getting buy-in from key stakeholders. The ideal candidate will have a solid track-record demonstrating strong business acumen, where s/he has successfully taken ideas from inception to completion. Supervisory responsibility: (if applicable) Lead and manage a team that is accountable for the professional strategies to drive system adoption and consumable growth for the Body Contouring division. KEY DUTIES AND RESPONSIBILITIES: Describe scope: % of Time or Importance Responsible for leading a comprehensive commercialization plan, developing HCP product positioning, core messages, growth strategy and annual marketing plan. Analyze competitive promotional activity and implement appropriate actions. Reviews and responds to changing market dynamics, as indicated through market analysis, customer interaction and sales input, to ensure achievement of goals by directing activities to a rapidly evolving landscape. Provide ongoing program leadership, supervise vendors and agencies and support field execution. Monitor and accelerate program performance through sales and ROI analysis. Contribute towards achieving brand financial and market share goals, manage promotional budget, deliver quarterly profit targets 40% Drive CoolSculpting commercial programs through a collaborative approach with sales and consumer marketing team (ADL) to develop and execute highly effective commercial impact with customers. These programs should incorporate KOL / advisory board feedback from customers. Responsible for overseeing management of all professional program related education, managing the commercial programs budget and external vendors to ensure efficient use of funds, ROI against set objectives and optimal customer service to our customers. 25% Oversee the development and management of promotional programs and tools: Lead the team to develop promotional tactics and sales tools that support brand strategies for capital equipment and consumable businesses. Collaborate with Regulatory, Medical, Legal, Compliance in development of all promotional pieces and programs. Effectively and collaboratively manage agency partners. Participate as appropriate in meetings with Global Commercial Development, Med Affairs, and International Brand teams. 20% Develops and maintains a customer focus that includes effective working relationships with KOL customers (HCP's and CS Specialists) in conjunction with strategy and campaign development. Provide sales team leadership and training, work with field sales representatives on a regular basis, support field training as needed, attend major conventions and meetings, educational and prospecting programs and events. 15% Qualifications job QUALIFICATIONS (MINIMUM REQUIREMENTS): Requirements: Minimum 15+ years of professional industry experience, including at least 3+ years in managerial positions at a medium-to-large health care company (device, phamra, OTC or FMCG). 5+ years professional/consumer marketing- Medical Device preferred but not mandatory. Knowledge of health care and/or Medical Device industry preferred (not mandatory). Solid knowledge of marketing areas including product positioning, marketing plan development and execution, strategic communications, product launch etc. Successful track record of strategic and tactical marketing. Experience launching Medical Devices preferred. Essential Skills, and Competencies: Proven leadership ability to work effectively and influences through others Financial/budgetary experience Ability to analyze difficult, complex situations, understand the details, and not get lost in them Ability to make difficult decisions, deal quickly and effectively with changes, and confront conflict constructively (strong resolution skills) Excellent communication skills, both oral and written, with an ability to make effective presentations to customers, sales team, and senior management Ability to appropriately prioritize and execute multiple critical issues Strong interpersonal skills, managing multiple stakeholders in a changing and flexible environment Willingness to travel 40% of the time Significant Work Activities N/A Travel Yes, 5 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. What Your New Manager Wants You To Know The Associate Director Regulatory Affairs represents Regulatory Affairs for pharmaceutical development projects and marketed products. Responsible for development and communication of all aspects of regulatory strategy on R&D project teams. Works with a team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions (e.g. US, Canada EU, APAC) with responsibility for working with colleagues on a worldwide basis to support the global strategy. Responsible for content of all regulatory submissions. Acts as primary contact for the US FDA. Directs communications and interactions with US FDA and other regulatory agencies as assigned. Ensures technical accuracy and regulatory compliance of all submissions. Ensures that all submissions are made on time. Primary responsibility is in the Neuroscience TA. YOU ARE more than just a title, YOU ARE... First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Represent Department on Global Project Team. Develop regulatory strategic plan in consultation with the global regulatory project team. Work with team to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Set strategy for submissions of product registration documents to Health Authorities. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions. Responsible for US and Canada submissions (strategy and submission preparation). Clearly articulate regulatory strategy at Global Regulatory Project Team meetings. Negotiate with teams to assure acceptance of regulatory strategy. Assure compliance with project team timelines and milestones. Effectively plan, organize, and conduct formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact Abbvie's products and operations. Advise personnel in other departments regarding their applicability and impact. #LI-PD1 Qualifications You Bring Education equivalent to a PhD or MD degree or equivalent in a scientific field, plus at least 6 years' experience in Regulatory Affairs with successful leadership roles on global project teams; or Education equivalent to a MS degree or equivalent in a scientific field, plus at least 8 years' experience in Regulatory Affairs with successful leadership roles on global project teams; or Education equivalent to a BS degree or equivalent in a scientific field, plus at least 10 years' experience in Regulatory Affairs with successful leadership roles on global project teams; Demonstrated excellence in developing global regulatory affairs strategy Expert knowledge of US, Canada and ICH regulations. Experience with European, Japanese and Chinese regulations is a plus. Ability to travel up to 15% In this role, we're looking for a leader who will : • Act as an Owner • Be Excellence Focused • Act as an Influencer Significant Work Activities N/A Travel Yes, 15 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/23/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. What Your New Manager Wants You To Know The Associate Director Regulatory Affairs represents Regulatory Affairs for pharmaceutical development projects and marketed products. Responsible for development and communication of all aspects of regulatory strategy on R&D project teams. Works with a team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis. Responsible for knowledge of regulatory requirements of major regions (e.g. US, Canada EU, APAC) with responsibility for working with colleagues on a worldwide basis to support the global strategy. Responsible for content of all regulatory submissions. Acts as primary contact for the US FDA. Directs communications and interactions with US FDA and other regulatory agencies as assigned. Ensures technical accuracy and regulatory compliance of all submissions. Ensures that all submissions are made on time. Primary responsibility is in the Neuroscience TA. YOU ARE more than just a title, YOU ARE... First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will Represent Department on Global Project Team. Develop regulatory strategic plan in consultation with the global regulatory project team. Work with team to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Set strategy for submissions of product registration documents to Health Authorities. Interact with other line functions in the preparation, review, and completion of documents for regulatory submissions. Responsible for US and Canada submissions (strategy and submission preparation). Clearly articulate regulatory strategy at Global Regulatory Project Team meetings. Negotiate with teams to assure acceptance of regulatory strategy. Assure compliance with project team timelines and milestones. Effectively plan, organize, and conduct formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications. Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact Abbvie's products and operations. Advise personnel in other departments regarding their applicability and impact. #LI-PD1 Qualifications You Bring Education equivalent to a PhD or MD degree or equivalent in a scientific field, plus at least 6 years' experience in Regulatory Affairs with successful leadership roles on global project teams; or Education equivalent to a MS degree or equivalent in a scientific field, plus at least 8 years' experience in Regulatory Affairs with successful leadership roles on global project teams; or Education equivalent to a BS degree or equivalent in a scientific field, plus at least 10 years' experience in Regulatory Affairs with successful leadership roles on global project teams; Demonstrated excellence in developing global regulatory affairs strategy Expert knowledge of US, Canada and ICH regulations. Experience with European, Japanese and Chinese regulations is a plus. Ability to travel up to 15% In this role, we're looking for a leader who will : • Act as an Owner • Be Excellence Focused • Act as an Influencer Significant Work Activities N/A Travel Yes, 15 % of the Time Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . This position is responsible for overseeing International Public Affairs strategies and tactics to drive AbbVie's business in Oncology and Specialty Care, including Virology and Neuroscience. The role reports to the Senior Director, International Public Affairs and has accountability for the outcome of communication and patient relations activities within Oncology and Specialty, that have an impact on the broader reputation of the Company. The role sits on Oncology and Specialty leaderships for Global Marketing and Commercial Operations (GMCO), Global Commercial Development (GCD), as well on the respective TA Strategy Councils (TASCs) and relevant Asset Strategy Teams (AST), to contribute to the development of business strategies and acts as a strategic counsellor to these teams. This role also must work very closely with all relevant departments within AbbVie, particularly Corporate Responsibility, Communications and Brand, Marketing, Medical, Regulatory, Government Affairs, Market Access, HEOR and others, as relevant. The role manages three direct reports and an annual budget of ~$3MM. Major Accountabilities Specific functions performed include strategic stakeholder engagement for Oncology and Specialty, oversee affiliate launch readiness and conduct general affiliate preparedness. The role also oversees media relations and issues management for the respective TAs. Manages and develops a public affairs team responsible for developing communications strategies and plans that support overall business objectives for on-market and pipeline compounds. Has functional accountability over affiliate launch success for Oncology and Specialty medicines Has functional accountability over global brand plan execution for Oncology and Specialty marketed medicines. Provides strategic counsel and contributes significantly to the decisions of management, Oncology and Specialty leaderships, global brand teams and other internal stakeholders on courses of action to address proactive opportunities and manage issues. Links brand and therapeutic area public affairs strategies to overall CRBC strategic roadmap priorities. Works collaboratively with Areas and Affiliates, leading the co-creation of therapeutic area programs/plans against a strategic communications plan that advances brand reputation, shapes the healthcare environment and advances understanding of priority disease areas and the success of AbbVie medicines as defined by the global brand teams. Analyzes the surrounding environment and gathers stakeholder insights to inform global strategic planning, objectives and key business decisions. Anticipates potential issues and develop/implement appropriate actions to protect the Company and brands he/she is responsible for. Works closely with media from relevant countries to build an understanding and appreciation of the therapeutic area, brand(s), the Company and business priorities. Establishes media engagement plans that elevate the reputation of the brand(s), as per the priorities defined in collaboration with the brand teams. Acts as spokesperson where relevant. Develops and leads strategic patient advocacy programs, builds rapport and manages relationships with prioritized advocacy groups and patient organizations. Can oversee the strategy and execution of internal communication programs on behalf of the global teams. Facilitates internal global best practice sharing on brand communications. Consistently measures the success of the initiatives developed against the set of goals and integrates the learnings back into strategy design seeking permanent improvement. Supervises PR firms, outside vendors, contractors, etc. Responsible for talent development and succession planning for direct reports. Manages the department budget; oversees PR spend of several million dollars. Complies and is an advocate for the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie. Qualifications Qualification Requirements Minimum of Bachelor's degree in communications, PR, marketing or related field. Minimum 10-15 years of directly relevant communications experience with international healthcare and/or industry experience required. Very strong business and marketing acumen. Demonstrated expertise in developing and executing insight-driven, strategic and measurable external public relations programs on behalf of pharmaceutical and/or consumer products. Proven track record of working with senior executives and leading teams. Strong understanding about the value of public relations and its role in the integrated marketing mix. Ability to provide strategic counsel for a variety of communications scenarios and to a variety of internal and external stakeholders. Exceptional verbal and written communication skills. Proven creativity, strategic, analytical and leadership capabilities. Demonstrated ability to work effectively in cross-functional teams and with multiple internal and external stakeholders; influence/negotiation skills and relationship management capabilities a must. Experience counselling senior business leaders on diverse, high profile and financially-material topics. Proven experience in issues/crises management. Strong interpersonal skills to quickly build rapport and credibility with AbbVie affiliates and leaders as well as other key internal and external stakeholders. Significant Work Activities N/A Travel Yes, 20 % of the Time Job Type Experienced Schedule Full-time Job Level Code D Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/20/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . This position is responsible for overseeing International Public Affairs strategies and tactics to drive AbbVie's business in Oncology and Specialty Care, including Virology and Neuroscience. The role reports to the Senior Director, International Public Affairs and has accountability for the outcome of communication and patient relations activities within Oncology and Specialty, that have an impact on the broader reputation of the Company. The role sits on Oncology and Specialty leaderships for Global Marketing and Commercial Operations (GMCO), Global Commercial Development (GCD), as well on the respective TA Strategy Councils (TASCs) and relevant Asset Strategy Teams (AST), to contribute to the development of business strategies and acts as a strategic counsellor to these teams. This role also must work very closely with all relevant departments within AbbVie, particularly Corporate Responsibility, Communications and Brand, Marketing, Medical, Regulatory, Government Affairs, Market Access, HEOR and others, as relevant. The role manages three direct reports and an annual budget of ~$3MM. Major Accountabilities Specific functions performed include strategic stakeholder engagement for Oncology and Specialty, oversee affiliate launch readiness and conduct general affiliate preparedness. The role also oversees media relations and issues management for the respective TAs. Manages and develops a public affairs team responsible for developing communications strategies and plans that support overall business objectives for on-market and pipeline compounds. Has functional accountability over affiliate launch success for Oncology and Specialty medicines Has functional accountability over global brand plan execution for Oncology and Specialty marketed medicines. Provides strategic counsel and contributes significantly to the decisions of management, Oncology and Specialty leaderships, global brand teams and other internal stakeholders on courses of action to address proactive opportunities and manage issues. Links brand and therapeutic area public affairs strategies to overall CRBC strategic roadmap priorities. Works collaboratively with Areas and Affiliates, leading the co-creation of therapeutic area programs/plans against a strategic communications plan that advances brand reputation, shapes the healthcare environment and advances understanding of priority disease areas and the success of AbbVie medicines as defined by the global brand teams. Analyzes the surrounding environment and gathers stakeholder insights to inform global strategic planning, objectives and key business decisions. Anticipates potential issues and develop/implement appropriate actions to protect the Company and brands he/she is responsible for. Works closely with media from relevant countries to build an understanding and appreciation of the therapeutic area, brand(s), the Company and business priorities. Establishes media engagement plans that elevate the reputation of the brand(s), as per the priorities defined in collaboration with the brand teams. Acts as spokesperson where relevant. Develops and leads strategic patient advocacy programs, builds rapport and manages relationships with prioritized advocacy groups and patient organizations. Can oversee the strategy and execution of internal communication programs on behalf of the global teams. Facilitates internal global best practice sharing on brand communications. Consistently measures the success of the initiatives developed against the set of goals and integrates the learnings back into strategy design seeking permanent improvement. Supervises PR firms, outside vendors, contractors, etc. Responsible for talent development and succession planning for direct reports. Manages the department budget; oversees PR spend of several million dollars. Complies and is an advocate for the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie. Qualifications Qualification Requirements Minimum of Bachelor's degree in communications, PR, marketing or related field. Minimum 10-15 years of directly relevant communications experience with international healthcare and/or industry experience required. Very strong business and marketing acumen. Demonstrated expertise in developing and executing insight-driven, strategic and measurable external public relations programs on behalf of pharmaceutical and/or consumer products. Proven track record of working with senior executives and leading teams. Strong understanding about the value of public relations and its role in the integrated marketing mix. Ability to provide strategic counsel for a variety of communications scenarios and to a variety of internal and external stakeholders. Exceptional verbal and written communication skills. Proven creativity, strategic, analytical and leadership capabilities. Demonstrated ability to work effectively in cross-functional teams and with multiple internal and external stakeholders; influence/negotiation skills and relationship management capabilities a must. Experience counselling senior business leaders on diverse, high profile and financially-material topics. Proven experience in issues/crises management. Strong interpersonal skills to quickly build rapport and credibility with AbbVie affiliates and leaders as well as other key internal and external stakeholders. Significant Work Activities N/A Travel Yes, 20 % of the Time Job Type Experienced Schedule Full-time Job Level Code D Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . The Director of Regulatory Affairs - Device/Combination products supports regulatory objectives for the company's development and marketed device/combination products including coordination, management of global submissions and CE technical files/design dossiers. Directs and supports submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), post-approval reports, annual reports, export certificates, establishment registrations and device listings. Supports the development of the device regulatory strategy and provides device input into the preparation and maintenance of chemistry, manufacturing and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the assigned medical device or device aspect of combination products. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support Allergan at Regulatory Authority/Notified Body project-specific meetings as well as industry meetings. Provide regulatory support, project management and leadership for the (Medical Device Regulation - MDR and IVDR) implementation globally. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all Allergan policies and procedures. Key Duties / Responsibilities: Leads and/or supports device/combo product development and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the device/combination product. Supports regulatory submissions, regulatory operations, field actions, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of EC Declaration of Conformity as applicable, per product type. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs. Provides regulatory policy, intelligence interpretation and strategy (e.g. Medical Device Regulation) for device/combination products to support global regulatory plans, due diligence, integrations and divestitures. Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Cultivates meaningful and credible partnerships with external subject matter experts, Notified Bodies and regulatory agencies in the development of regulatory policies and assessments. Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety, International Regulatory Affairs and external third party regulatory experts. Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability Supports and develops global regulatory teams to meet company objectives. In addition, the incumbent is the key regulatory contact for International Regulatory Affairs. Qualifications Bachelor's degree in scientific discipline is required. A Master's degree in a scientific discipline or regulatory and/or law discipline or J.D. is highly desirable. 12 years of regulatory experience in the medical device/combination products industry; OR a Master's degree, or JD with a minimum of 8years of Regulatory experience in the medical device and combination products industry. Experience in the CE Marking process, global regulatory strategy and regulatory submission process. Sound technical skills including working knowledge of medical device and combination products. Experience with eCTD tools and EDMS applications. Proven experience in and ability to manage relationships with regulatory agency personnel at all levels. Strong knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends, making recommendations to senior management to drive proactive initiatives to ensure compliance for Device/Combination Products. Strong knowledge of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 600, 700, 807, 809, 803, 812, 814, 312, 314, 1271, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, CMDR SOR/98-282, TGA SR. 236:2002, ANVISA RDC No. 16, JPAL Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for Allergan's devices and combination products. Ability to travel up to [15] % of time Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/16/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . The Director of Regulatory Affairs - Device/Combination products supports regulatory objectives for the company's development and marketed device/combination products including coordination, management of global submissions and CE technical files/design dossiers. Directs and supports submission activities for a variety of device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), post-approval reports, annual reports, export certificates, establishment registrations and device listings. Supports the development of the device regulatory strategy and provides device input into the preparation and maintenance of chemistry, manufacturing and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the assigned medical device or device aspect of combination products. Supports regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support Allergan at Regulatory Authority/Notified Body project-specific meetings as well as industry meetings. Provide regulatory support, project management and leadership for the (Medical Device Regulation - MDR and IVDR) implementation globally. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations and regulatory guidance as well as all Allergan policies and procedures. Key Duties / Responsibilities: Leads and/or supports device/combo product development and global filing activities from a regulatory standpoint from initial product concept through life cycle management of the device/combination product. Supports regulatory submissions, regulatory operations, field actions, change control, lifecycle management, interactions with regulatory agencies/Notified Bodies, technical file/design dossier management and approval of EC Declaration of Conformity as applicable, per product type. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety and International Regulatory Affairs. Provides regulatory policy, intelligence interpretation and strategy (e.g. Medical Device Regulation) for device/combination products to support global regulatory plans, due diligence, integrations and divestitures. Acts as a key regulatory advisor to provide strategy and leadership by partnering with operating units on the implementation and training of regulatory requirements. Cultivates meaningful and credible partnerships with external subject matter experts, Notified Bodies and regulatory agencies in the development of regulatory policies and assessments. Participates in and contributes to industry and professional meetings to maintain competency on regulatory policy issues. In addition, the incumbent is the key regulatory contact for Quality, Medical Safety, International Regulatory Affairs and external third party regulatory experts. Provides leadership, remains accessible and coaches employees when needed; maintains high levels of work and employee accountability Supports and develops global regulatory teams to meet company objectives. In addition, the incumbent is the key regulatory contact for International Regulatory Affairs. Qualifications Bachelor's degree in scientific discipline is required. A Master's degree in a scientific discipline or regulatory and/or law discipline or J.D. is highly desirable. 12 years of regulatory experience in the medical device/combination products industry; OR a Master's degree, or JD with a minimum of 8years of Regulatory experience in the medical device and combination products industry. Experience in the CE Marking process, global regulatory strategy and regulatory submission process. Sound technical skills including working knowledge of medical device and combination products. Experience with eCTD tools and EDMS applications. Proven experience in and ability to manage relationships with regulatory agency personnel at all levels. Strong knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends, making recommendations to senior management to drive proactive initiatives to ensure compliance for Device/Combination Products. Strong knowledge of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 600, 700, 807, 809, 803, 812, 814, 312, 314, 1271, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, CMDR SOR/98-282, TGA SR. 236:2002, ANVISA RDC No. 16, JPAL Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for Allergan's devices and combination products. Ability to travel up to [15] % of time Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global, US and Canadian regulatory strategies to secure and maintain market approval in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT), expands TA knowledge, and manages strategic messaging and content of global, US and Canadian regulatory dossiers. Serves as the primary regulatory interface with ADT and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Ensures alignment of global regulatory strategies with Sr. management. May have direct reports. Key Responsibilities: Leads a team of global regulatory professionals for development and marketed products. Accountable for ensuring that corporate goals are met. Manages the content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy for assigned products. Leads preparation of global, US and Canadian regulatory product strategies for assigned products. Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products. Acts independently under the direction of a GPS TA Head. May participate in or lead initiatives. Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for GRPT members. May have direct report and contributes to the performance management for other RA team members. Influences the development of regulations and guidance. Advises management of the effect of current or proposed laws, regulations, guidelines and standards, etc. Advises internal personnel on regulatory strategies. Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department and , if applicable, ensures direct reports follow requirements. Ensures alignment of global regulatory strategies with Sr. Management. Proactively informs ADT and management of issues, risks and mitigations. Provides assessment of impact on global, US and Canadian programs. Provides informed regulatory opinion based on experience and expertise. Works with GRPT to develop, communicate goals that are in alignment with the business goals. Under supervision of a Director or TA Head, communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by executive management. Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Advances the organization's goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects. Follows budget allocations and keeps supervisor informed on project resourcing. Qualifications Required Education:Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject. Preferred Education:Relevant advanced degree is preferred. Certification a plus. Required Experience:7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US& Canada region. Proven 3-5 years in a leadership role with strong management skills.Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams. Required Experience (continued):Strong communication and proactive negotiation skills. Experience contributing to enterprise management of a portfolio of products. Experience interfacing with government regulatory agencies. Experience developing and implementing successful global regulatory strategies. Preferred Experience:10 years' experience in pharmaceutical regulatory activities; preferably with experience as lead regulatory product strategist in two or more major regions such as EU or Japan.Strong clinical foundation preferred with business acumen.Note: Higher education may compensate for years of experience. Significant Work Activities Keyboard use (greater or equal to 50% of the workday) Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel Yes, 25 % of the Time Job Type Experienced Schedule Full-time Job Level Code D Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
01/15/2021
Full time
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global, US and Canadian regulatory strategies to secure and maintain market approval in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT), expands TA knowledge, and manages strategic messaging and content of global, US and Canadian regulatory dossiers. Serves as the primary regulatory interface with ADT and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Demonstrates understanding of drug development and leadership behaviors consistent with level. Develops and implements acceleration strategies. Ensures alignment of global regulatory strategies with Sr. management. May have direct reports. Key Responsibilities: Leads a team of global regulatory professionals for development and marketed products. Accountable for ensuring that corporate goals are met. Manages the content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy for assigned products. Leads preparation of global, US and Canadian regulatory product strategies for assigned products. Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products. Acts independently under the direction of a GPS TA Head. May participate in or lead initiatives. Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for GRPT members. May have direct report and contributes to the performance management for other RA team members. Influences the development of regulations and guidance. Advises management of the effect of current or proposed laws, regulations, guidelines and standards, etc. Advises internal personnel on regulatory strategies. Follows company policies and procedures for regulatory record keeping and may develop and implement policies and procedures within the RA department and , if applicable, ensures direct reports follow requirements. Ensures alignment of global regulatory strategies with Sr. Management. Proactively informs ADT and management of issues, risks and mitigations. Provides assessment of impact on global, US and Canadian programs. Provides informed regulatory opinion based on experience and expertise. Works with GRPT to develop, communicate goals that are in alignment with the business goals. Under supervision of a Director or TA Head, communicates to regulatory team and cross-functionally the immediate to long-range plans to carry out objectives established by executive management. Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Advances the organization's goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects. Follows budget allocations and keeps supervisor informed on project resourcing. Qualifications Required Education:Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject. Preferred Education:Relevant advanced degree is preferred. Certification a plus. Required Experience:7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US& Canada region. Proven 3-5 years in a leadership role with strong management skills.Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams. Required Experience (continued):Strong communication and proactive negotiation skills. Experience contributing to enterprise management of a portfolio of products. Experience interfacing with government regulatory agencies. Experience developing and implementing successful global regulatory strategies. Preferred Experience:10 years' experience in pharmaceutical regulatory activities; preferably with experience as lead regulatory product strategist in two or more major regions such as EU or Japan.Strong clinical foundation preferred with business acumen.Note: Higher education may compensate for years of experience. Significant Work Activities Keyboard use (greater or equal to 50% of the workday) Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel Yes, 25 % of the Time Job Type Experienced Schedule Full-time Job Level Code D Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.