Halloran Consulting Group, Inc.

Senior Director, Regulatory Strategy Consulting Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran's Regulatory team as a Senior Director, Regulatory Strategy Consulting today! Reporting to the Vice President of Regulatory Affairs, this leader will shape and drive global regulatory strategies across diverse therapeutic portfolios. In this role, you will combine deep regulatory expertise, strategic foresight, and business development acumen to deliver innovative solutions for our clients. You will lead cross functional teams, represent clients in critical health authority engagements, and act as a trusted partner to senior leadership. The ideal candidate thrives at the intersection of strategy and execution, balancing technical mastery with consultative leadership to deliver meaningful impact for clients and the organization. Regulatory Strategic Leadership Provide regulatory strategy and leadership to our clients through design and implementation of global regulatory strategies across development programs, proactively identify and mitigate regulatory risks to ensure alignment with client business objectives. Lead the planning of major global regulatory submissions (INDs, CTAs, NDAs, BLAs) and responses, represent the client in meetings with FDA and global health authorities, lead rehearsals, and moderate live health authority meetings and partner with internal teams and external client teams / vendors to ensure quality, timely, and compliant regulatory submissions and deliverables. Drive delivery team accountability for regulatory milestones and timelines; elevate and resolve critical path issues. Meet a target billable utilization of 50% while driving client satisfaction and delivery excellence. Team Leadership and Talent Development Provide line management and performance management to inform optimal resource planning and oversee billable utilization tracking for direct reports. Support team capacity planning and utilization trending to ensure optimal resourcing and project delivery across the portfolio of projects. Coach and mentor and guide regulatory teams, to demonstrate the tools, skills, and resources needed to perform their job responsibilities. Foster a culture of innovation, collaboration, and continuous professional development. Business Development and Account Growth Partner with Business Development leadership to foster the continuation and of strong, long term relationships with clients and identify expansion opportunities for Halloran services. This includes participation in BD calls as the subject matter expert (SME), contributing and participating in generating a Response For Proposal (RFP), proposal development, BID defence meeting(s), as the SME. Build and maintain strong relationships with clients to expand existing client relationships and identify new opportunities through consultative expertise and industry engagement. This will involve working closely with clients to understand their needs, leveraging the collective team to develop product specific strategies and solutions that meet client needs. Ensure that clients are satisfied with the quality of our delivery product. Understanding of industry trends and dynamics and the competitive marketplace to support business growth initiatives. Identify new business and expand active accounts through networking, industry events, maintenance of client relationships and professional associations. Operational Excellence and Process Improvement Drive efficiencies across regulatory consulting processes, embedding best practices and governance mechanisms for consistent, high quality execution. Thought Leadership and Industry Impact Contribute to thought leadership rainmaking activities to influence and provide perspectives to our industry and clients. Generate content (whitepapers, case studies) to showcase expertise and shape industry perspectives. Provide presence at industry events, conferences and forums. Support the development of marketing materials and social media posts that showcase Halloran's expertise and breadth of expertise. Other related duties and projects as required and assigned. Qualifications Required: Bachelor's degree in scientific discipline with at least 15 years of Regulatory Affairs experience in the biotechnology and/or pharmaceutical industry. Prior consulting or service provider experience and a demonstrated ability in managing high profile accounts and fostering client satisfaction. Strong leadership skills in line management, coaching, and team development. Proven track record leading cross functional, multi disciplinary teams and managing complex, high profile regulatory submissions. Strong business development skills with experience in winning new business, expanding accounts, and serving as SME in client engagements. Demonstrated strength in risk management, compliance governance, and process optimization. Preferred: Advanced degree (PhD, PharmD, MD, or MSc) and/or RAC certification. Expertise within regulatory strategy, product development, and/or regulatory CMC. Experience across multiple product types (e.g., biologics (proteins, mABs, ADCs), small molecules, cell and gene therapy, oligonucleotides, peptides). Experience in central nervous system (neurology / psychology), metabolic, oncology, or rare diseases. Compensation The targeted base compensation range for this position is between $200,000.00 and $260,000.00 annually. Please note: this compensation range is Halloran's good faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, Halloran may ultimately pay more or less than the posted range. Halloran Benefits and Perks The benefits of being a Halloran employee go beyond the unparalleled opportunities of your day to day work! We offer an annual, discretionary bonus based on company and individual performance, comprehensive Medical, Dental, and Vision Insurance, and a 401(k) Plan for all full time employees. In addition to this, Halloran offers a flexible PTO Policy and opportunities for continued learning. Notice Halloran does not sponsor visas for employees. All remote employees are expected to have a consistent home internet connection with speeds of at least 25Mbps while working remotely. Halloran Consulting Group, Inc. is an equal opportunity employer committed to diversity, equity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local nondiscrimination laws. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.