Executive Director, Regulatory Affairs

Job Title: Executive Director, Global Regulatory Affairs Department: Regulatory Affairs Reports To: Vice President, Regulatory Affairs / Sr. Vice President, Regulatory Affairs Location: Boston, MA Date Prepared: March 27, 2026 Job Summary The Executive Director, Global Regulatory Affairs will provide strategic and operational leadership for global regulatory activities across the company's oncology portfolio and will be accountable for the development and execution of integrated global regulatory strategies across the full product lifecycle, from early clinical development through registration, commercialization, and postapproval lifecycle management. Serving as a senior member of the Regulatory Affairs leadership team, this role will oversee multiple oncology programs and/or therapeutic areas and will act as a key regulatory advisor to executive leadership and cross‑functional governance bodies. The Executive Director will ensure that regulatory strategies are aligned with corporate objectives, development priorities, and commercial goals, while enabling efficient and compliant pathways to approval in major global markets. This position requires deep regulatory expertise in oncology drug and biologic development, strong leadership and decision‑making capabilities, and the ability to influence at the enterprise level. The Executive Director will lead global Health Authority engagement strategies, drive regulatory excellence across the organization, and build and mentor high‑performing regulatory teams in a dynamic oncology biotech environment. Principal Duties Provide executive‑level regulatory leadership and oversight for assigned oncology programs and/or portfolio segments, ensuring the development and execution of robust global regulatory strategies across the full product lifecycle, from early clinical development through registration, commercialization, and post‑approval activities. Serve as, or oversee, Global Regulatory Leaders (GRLs) for oncology programs, ensuring consistent, high‑quality regulatory strategy development and execution across programs, indications, and regions. Accountable for regulatory strategy input into corporate, portfolio, and development governance, including assessment of regulatory risk, probability of success, and mitigation strategies to support informed decision‑making by senior leadership. Lead and oversee global Health Authority engagement strategies, including FDA, EMA, and other international regulatory agencies, and provide executive oversight for major regulatory interactions (e.g., preIND, End‑of‑Phase, scientific advice, preBLA/MAA). Ensure the preparation, review, and approval of high‑quality regulatory submissions and related documentation, including but not limited to INDs/CTAs, scientific advice packages, orphan drug applications, PIPs/PSPs, BLAs/MAAs, labeling strategy and negotiations, responses to regulatory questions, and post‑approval commitments. Provide strategic oversight for regulatory approaches involving companion diagnostics (CDx), biomarkers, devices, and combination products, ensuring alignment of therapeutic and diagnostic development strategies. Drive the evaluation and application of special regulatory pathways and expedited programs (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, PRIME, compassionate use, pediatric plans, diversity action plans), ensuring alignment with program and portfolio objectives. Maintain a high level of regulatory intelligence and competitive awareness, monitoring evolving regulatory requirements, precedents, and external trends, and proactively adapting regulatory strategies to maintain competitive advantage. Partner closely with Clinical Development, Clinical Operations, CMC/Technical Operations, Nonclinical, Biometrics, Medical Affairs, Commercial, and Project Management to ensure regulatory considerations are fully integrated into development and commercialization plans. Represent Regulatory Affairs as a senior leader within cross‑functional teams, Global Product Teams, and internal governance forums, and serve as a key regulatory spokesperson for the company as appropriate. Build, lead, and develop a high‑performing Regulatory Affairs organization by setting clear expectations, providing mentorship and career development, and fostering a culture of accountability, collaboration, and regulatory excellence. Ensure compliance with global regulatory requirements and internal policies, and support continuous improvement of regulatory processes, systems, and capabilities to support organizational growth. Required Qualifications/Experience (Basic Qualifications) Education Bachelor's degree in Life Sciences or a related discipline required; advanced scientific degree (MS, PhD, PharmD, MD, or equivalent) strongly preferred. Experience 15+ years of progressive Regulatory Affairs experience within the pharmaceutical and/or biotechnology industry (small molecule and/or well‑characterized biologics). Demonstrated success leading global regulatory strategies for multiple development programs across clinical stages (Phase 1‑4), including experience with global registrations. Proven experience interacting with global Health Authorities (e.g., FDA, EMA) at a senior level. Experience negotiating patient‑reported outcomes and other clinical outcomes assessments with FDA and/or EMA. Experience in oncology and/or rare diseases is required. Demonstrated experience managing and developing senior regulatory leaders and teams as a player/coach in a matrixed, cross‑functional environment. Skills Demonstrated deep knowledge of global regulatory requirements governing oncology drug and biologic development. Demonstrated strong strategic thinking, risk assessment, and decision‑making capabilities. Ability to influence and collaborate effectively with executive leadership and cross‑functional stakeholders. Excellent written and verbal communication skills, including the ability to communicate complex regulatory issues to executive leadership. Experience with electronic submission processes and global regulatory information management systems. E‑Equal Opportunity All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. #J-18808-Ljbffr