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

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.

• 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…