Senior Director Regulatory Affairs
Meet Life Sciences, Boston, MA, United States
Job Title: Senior Director, Regulatory Affairs – Oncology
Position Summary
The Senior Director of Regulatory Affairs will provide strategic leadership for global regulatory activities supporting the development and approval of oncology therapeutics. This individual will be responsible for designing and executing regulatory strategies to support clinical development programs and successful New Drug Application (NDA) submissions. The role will serve as a key regulatory leader within cross‑functional teams and will act as the primary regulatory interface with the U.S. FDA and other global health authorities.
Key Responsibilities
- Lead the development and execution of global regulatory strategies for oncology drug development programs from early clinical development through marketing approval.
- Provide regulatory leadership for NDA submissions, including planning, content oversight, review, and submission management.
- Serve as the primary regulatory contact for the FDA, including leading agency meetings (Pre‑IND, End‑of‑Phase, Pre‑NDA, and AdCom preparations).
- Guide regulatory strategy for clinical trial applications, protocol amendments, and lifecycle management activities.
- Ensure regulatory strategies align with clinical, CMC, and commercial objectives to support accelerated development timelines.
- Lead cross‑functional regulatory subteams and collaborate closely with Clinical Development, Clinical Operations, CMC, Quality, Pharmacovigilance, and Commercial teams.
- Oversee preparation and review of regulatory documents including briefing books, IND amendments, NDA modules, and responses to health authority questions.
- Identify regulatory risks and propose mitigation strategies to maintain development timelines.
- Monitor evolving global regulatory requirements and oncology guidance to ensure compliance and competitive positioning.
- Mentor and develop regulatory affairs staff and contribute to building a high‑performing regulatory organization.
Qualifications
- Advanced degree required (PhD, PharmD, MD, or MS in a relevant life sciences field preferred).
- Minimum 12–15 years of regulatory affairs experience in the biotechnology or pharmaceutical industry.
- Extensive oncology regulatory experience required.
- Demonstrated leadership of at least one successful NDA submission and approval in the United States.
- Strong knowledge of FDA regulations, ICH guidelines, and global regulatory frameworks.
- Experience interacting directly with FDA and leading regulatory agency meetings.
- Proven ability to influence cross‑functional teams and drive regulatory strategy in a fast‑paced development environment.
- Strong leadership, communication, and strategic thinking skills.
Preferred Experience
- Experience with expedited regulatory pathways (Breakthrough Therapy, Fast Track, Priority Review, Accelerated Approval).
- Experience with global submissions (MAA, PMDA, or other international filings).
- Prior leadership responsibility managing regulatory teams.
What We Offer
- Opportunity to shape regulatory strategy for innovative oncology therapies.
- Collaborative and science‑driven environment.
- Competitive compensation, bonus, and equity package.