Genmab
Princeton, New Jersey
At Genmab, we are dedicated to building extra not ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Position Summary The Global Medical Affairs Sr. Director will serve as the Global Medical Affairs Strategy Lead for Head and Neck Squamous Cell Carcinoma (HNSCC). This individual will be responsible for providing medical leadership and subject matter expertise in the development and execution of Global Medical Affairs strategic and tactical plans for HNSCC. The role will play a critical part in medical launch planning and execution, working in close alignment with the MASL and cross-functional partners. The position requires strong commercial aptitude and the ability to translate and align scientific and business objectives into actionable strategies and launch excellence experience. Key Responsibilities Lead the development and execution of the Global Medical Affairs (GMA) strategy for HNSCC, ensuring alignment with corporate objectives. Drive Global launch excellence for HNSCC assets, overseeing pre-launch planning, launch execution, and post-launch optimization. Co-lead Global Commercialization Team (GCT) to drive cross functional alignment across medical, regulatory, market access, clinical development, and regional teams to ensure globally consistent launch strategy. Manage and mentor direct reports, including the Launch Lead, to ensure delivery of strategic and tactical priorities. Provide medical monitoring and oversight for Medical Affairs-led interventional and observational clinical trials in HNSCC. Serve as the medical and content expert for HNSCC across internal and external stakeholders. Lead the planning and execution of Global advisory boards and Key Opinion Leader (KOL) engagements in HNSCC. Represent the company at major global medical conferences and meetings relevant to HNSCC. Oversee HNSCC Areas of Interest for external collaborations and provide scientific input and strategic direction to the Investigator-Sponsored Trial (IST) program in HNSCC. Contribute to Medical and Promotional Review Committees with HNSCC expertise. Collaborate with cross-functional partners (commercial, clinical development, HEOR, market access, medical communications) to ensure MA contribution to integrated launch and lifecycle strategies. Lead lifecycle management initiatives, including evidence generation and execution of Phase 3b/4 studies. Build strong network with thought leaders, patient advocacy groups, and institutions in the HNSCC community to strengthen external partnerships. Support HEOR initiatives and market access strategies to demonstrate product value in HNSCC to payers and access decision-makers. Qualifications Doctoral degree (MD, PhD) preferred. Minimum of 10 years of medical affairs and/or clinical, or experience in oncology, with direct expertise in Head and Neck Squamous Cell Carcinoma (HNSCC) preferred. Biotech/pharmaceutical industry experience, including successful pre-launch and launch within Oncology/Hematology or solid tumors such as Thoracic and HNSCC. Strong commercial aptitude with ability to align scientific and business objectives. Demonstrated ability to work under pressure in a fast-paced environment with tight timelines. Proven track record in building, leading, and developing high performing teams, with demonstrated ability to inspire, mentor, and manage talent to achieve strategic objectives in complex, fast paced environments; Prior experience managing direct reports preferred. Collaborative leadership style with proven ability to build trusted partnerships across functions. Strong ability to interpret and articulate clinical and HEOR data. In-depth understanding of compliance and regulatory requirements in Medical Affairs, R&D, and Commercial. Knowledge of evidence-based medicine, applied biostatistics, and health economics desirable. Excellent organizational skills with ability to manage multiple projects simultaneously. Strong written and verbal communication skills, including presentation expertise. Ability to travel up to 25% of the time both nationally and internationally, including occasional weekends. Work arrangement: This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager. For US based candidates, the proposed salary band for this position is as follows: $253,440.00 $380,160.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
At Genmab, we are dedicated to building extra not ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Position Summary The Global Medical Affairs Sr. Director will serve as the Global Medical Affairs Strategy Lead for Head and Neck Squamous Cell Carcinoma (HNSCC). This individual will be responsible for providing medical leadership and subject matter expertise in the development and execution of Global Medical Affairs strategic and tactical plans for HNSCC. The role will play a critical part in medical launch planning and execution, working in close alignment with the MASL and cross-functional partners. The position requires strong commercial aptitude and the ability to translate and align scientific and business objectives into actionable strategies and launch excellence experience. Key Responsibilities Lead the development and execution of the Global Medical Affairs (GMA) strategy for HNSCC, ensuring alignment with corporate objectives. Drive Global launch excellence for HNSCC assets, overseeing pre-launch planning, launch execution, and post-launch optimization. Co-lead Global Commercialization Team (GCT) to drive cross functional alignment across medical, regulatory, market access, clinical development, and regional teams to ensure globally consistent launch strategy. Manage and mentor direct reports, including the Launch Lead, to ensure delivery of strategic and tactical priorities. Provide medical monitoring and oversight for Medical Affairs-led interventional and observational clinical trials in HNSCC. Serve as the medical and content expert for HNSCC across internal and external stakeholders. Lead the planning and execution of Global advisory boards and Key Opinion Leader (KOL) engagements in HNSCC. Represent the company at major global medical conferences and meetings relevant to HNSCC. Oversee HNSCC Areas of Interest for external collaborations and provide scientific input and strategic direction to the Investigator-Sponsored Trial (IST) program in HNSCC. Contribute to Medical and Promotional Review Committees with HNSCC expertise. Collaborate with cross-functional partners (commercial, clinical development, HEOR, market access, medical communications) to ensure MA contribution to integrated launch and lifecycle strategies. Lead lifecycle management initiatives, including evidence generation and execution of Phase 3b/4 studies. Build strong network with thought leaders, patient advocacy groups, and institutions in the HNSCC community to strengthen external partnerships. Support HEOR initiatives and market access strategies to demonstrate product value in HNSCC to payers and access decision-makers. Qualifications Doctoral degree (MD, PhD) preferred. Minimum of 10 years of medical affairs and/or clinical, or experience in oncology, with direct expertise in Head and Neck Squamous Cell Carcinoma (HNSCC) preferred. Biotech/pharmaceutical industry experience, including successful pre-launch and launch within Oncology/Hematology or solid tumors such as Thoracic and HNSCC. Strong commercial aptitude with ability to align scientific and business objectives. Demonstrated ability to work under pressure in a fast-paced environment with tight timelines. Proven track record in building, leading, and developing high performing teams, with demonstrated ability to inspire, mentor, and manage talent to achieve strategic objectives in complex, fast paced environments; Prior experience managing direct reports preferred. Collaborative leadership style with proven ability to build trusted partnerships across functions. Strong ability to interpret and articulate clinical and HEOR data. In-depth understanding of compliance and regulatory requirements in Medical Affairs, R&D, and Commercial. Knowledge of evidence-based medicine, applied biostatistics, and health economics desirable. Excellent organizational skills with ability to manage multiple projects simultaneously. Strong written and verbal communication skills, including presentation expertise. Ability to travel up to 25% of the time both nationally and internationally, including occasional weekends. Work arrangement: This role offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager. For US based candidates, the proposed salary band for this position is as follows: $253,440.00 $380,160.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit and follow us on LinkedIn and X . Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice () . Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
BESTMSLs
New York, New York
Associate Director, Medical Science Liaison, Respiratory (Northeast Territory) US-NY-New York Job ID: of Openings: 1 Category: Medical Science Liaison BESTMSLs Overview Field-Based Full-Time Therapeutic Area: Respiratory Territory: Northeast covering NY, NJ, DC, MD, DE, PA, CT, MA, RI, NH, ME Preferred home cities: New York City, Boston, Philadelphia, Washington DC A global biopharmaceutical organization is seeking an experienced Medical Science Liaison (MSL) at Associate Director level to support its US Respiratory portfolio. This role is a senior individual contributor position focused on scientific engagement, KOL relationship development, strategic insight generation, and medical education. This is a field-based position requiring significant travel within the assigned geography. About the Role The Associate Director, Medical Science Liaison - Respiratory serves as a scientific expert in the field and an extension of the Medical Affairs organization. The individual engages with healthcare professionals (HCPs), key opinion leaders (KOLs), academic institutions, and other external stakeholders in a non-promotional, scientifically rigorous manner. Responsibilities span scientific exchange, insight gathering, strategic planning, internal collaboration, and support of medical education initiatives. Responsibilities Scientific Exchange & Medical Education Deliver objective, evidence-based scientific information in a non-promotional manner. Use only approved medical materials during external engagements. Respond to unsolicited medical requests (UMRs) with accurate, balanced information. KOL & Stakeholder Relationship Management Develop, maintain, and execute individualized engagement plans for target KOLs and HCPs. Identify unmet medical education needs and assess competitive medical activity. Build strong, collaborative, and compliant relationships across the respiratory therapeutic landscape. Insight Generation & Internal Collaboration Capture, synthesize, and communicate field insights to inform Medical Affairs strategy and asset planning. Collaborate with internal medical leadership to develop new and innovative medical education resources (e.g., slide decks, digital content). Deliver advisory board, congress, and customer insight reports. Operational Excellence Maintain accurate documentation of HCP interactions in CRM platforms (e.g., VEEVA). Provide monthly activity summaries to internal leadership. Submit expenses, travel documentation, and administrative updates in a timely manner. Ensure full compliance with SOPs, medical governance, and applicable federal and state regulations. Congress, Events & Internal Contributions Staff Medical Affairs booths at scientific meetings and conventions. Participate in congresses, symposia, and other scientific engagements as needed. Provide internal therapeutic area training when appropriate and requested. Contribute to cross-functional initiatives, driving innovation and operational effectiveness. Other Responsibilities Continuously enhance scientific expertise and leadership capabilities. Perform additional duties as assigned. Qualifications Advanced degree (MD, PhD, or PharmD). Minimum 5 years of experience in MSL roles with a respiratory focus. Strong understanding of the Medical Science Liaison function, clinical trial design, evidence generation, and US Medical Affairs principles. Deep knowledge of relevant regulatory and compliance frameworks (PhRMA Code, FDA/OPDP guidance, HCP interaction standards, SOPs). Proven ability to communicate complex scientific data clearly and credibly. Demonstrated success building relationships with KOLs, investigators, PAGs, and academic partners. Strong analytical, organizational, and strategic planning skills. Ability to work semi-autonomously and thrive in a dynamic environment. High professional accountability, adaptability, and commitment to continuous development. Commitment to diversity, equity, and inclusion. Willingness and ability to travel extensively (70-80%, including overnights or weekends as needed). PIf941e3e9a93a-9443
Associate Director, Medical Science Liaison, Respiratory (Northeast Territory) US-NY-New York Job ID: of Openings: 1 Category: Medical Science Liaison BESTMSLs Overview Field-Based Full-Time Therapeutic Area: Respiratory Territory: Northeast covering NY, NJ, DC, MD, DE, PA, CT, MA, RI, NH, ME Preferred home cities: New York City, Boston, Philadelphia, Washington DC A global biopharmaceutical organization is seeking an experienced Medical Science Liaison (MSL) at Associate Director level to support its US Respiratory portfolio. This role is a senior individual contributor position focused on scientific engagement, KOL relationship development, strategic insight generation, and medical education. This is a field-based position requiring significant travel within the assigned geography. About the Role The Associate Director, Medical Science Liaison - Respiratory serves as a scientific expert in the field and an extension of the Medical Affairs organization. The individual engages with healthcare professionals (HCPs), key opinion leaders (KOLs), academic institutions, and other external stakeholders in a non-promotional, scientifically rigorous manner. Responsibilities span scientific exchange, insight gathering, strategic planning, internal collaboration, and support of medical education initiatives. Responsibilities Scientific Exchange & Medical Education Deliver objective, evidence-based scientific information in a non-promotional manner. Use only approved medical materials during external engagements. Respond to unsolicited medical requests (UMRs) with accurate, balanced information. KOL & Stakeholder Relationship Management Develop, maintain, and execute individualized engagement plans for target KOLs and HCPs. Identify unmet medical education needs and assess competitive medical activity. Build strong, collaborative, and compliant relationships across the respiratory therapeutic landscape. Insight Generation & Internal Collaboration Capture, synthesize, and communicate field insights to inform Medical Affairs strategy and asset planning. Collaborate with internal medical leadership to develop new and innovative medical education resources (e.g., slide decks, digital content). Deliver advisory board, congress, and customer insight reports. Operational Excellence Maintain accurate documentation of HCP interactions in CRM platforms (e.g., VEEVA). Provide monthly activity summaries to internal leadership. Submit expenses, travel documentation, and administrative updates in a timely manner. Ensure full compliance with SOPs, medical governance, and applicable federal and state regulations. Congress, Events & Internal Contributions Staff Medical Affairs booths at scientific meetings and conventions. Participate in congresses, symposia, and other scientific engagements as needed. Provide internal therapeutic area training when appropriate and requested. Contribute to cross-functional initiatives, driving innovation and operational effectiveness. Other Responsibilities Continuously enhance scientific expertise and leadership capabilities. Perform additional duties as assigned. Qualifications Advanced degree (MD, PhD, or PharmD). Minimum 5 years of experience in MSL roles with a respiratory focus. Strong understanding of the Medical Science Liaison function, clinical trial design, evidence generation, and US Medical Affairs principles. Deep knowledge of relevant regulatory and compliance frameworks (PhRMA Code, FDA/OPDP guidance, HCP interaction standards, SOPs). Proven ability to communicate complex scientific data clearly and credibly. Demonstrated success building relationships with KOLs, investigators, PAGs, and academic partners. Strong analytical, organizational, and strategic planning skills. Ability to work semi-autonomously and thrive in a dynamic environment. High professional accountability, adaptability, and commitment to continuous development. Commitment to diversity, equity, and inclusion. Willingness and ability to travel extensively (70-80%, including overnights or weekends as needed). PIf941e3e9a93a-9443
Larimar Therapeutics
Philadelphia, Pennsylvania
Description: Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to genetic abnormality. The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you! Position Summary: Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions. The Regulatory Affairs Director will be a key member of project teams. The role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: The Director of Regulatory Affairs ex-US will be a key member of project teams to define, develop and lead strategies to maximize global regulatory success towards achievement of program objectives for complex development projects Provide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings Develop internal regulatory procedures and practices Work closely with RA Sr. Director and serve as backup to other global region regulatory activity Requirements: Key Experience, Skills and Knowledge: Minimum of 4-year undergraduate degree 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Can do attitude, flexibility, and mental agility Equal Opportunity Employment We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the employment relationship with all employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI1712c7334b61-1144
Description: Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to genetic abnormality. The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you! Position Summary: Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions. The Regulatory Affairs Director will be a key member of project teams. The role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: The Director of Regulatory Affairs ex-US will be a key member of project teams to define, develop and lead strategies to maximize global regulatory success towards achievement of program objectives for complex development projects Provide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings Develop internal regulatory procedures and practices Work closely with RA Sr. Director and serve as backup to other global region regulatory activity Requirements: Key Experience, Skills and Knowledge: Minimum of 4-year undergraduate degree 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Can do attitude, flexibility, and mental agility Equal Opportunity Employment We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the employment relationship with all employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI1712c7334b61-1144