Senior Manager​/Associate Director, Regulatory Affairs

Overview

🚀 Now Hiring:
Senior Manager / Associate Director, Regulatory Affairs

Therapeutic Area: Rare Disease | Cell & Gene Therapy

We are seeking a highly motivated Senior Manager / Associate Director, Regulatory Affairs to join our expanding Regulatory team in Boston. This role will provide strategic regulatory leadership for innovative rare disease and cell & gene therapy programs
, supporting development from early clinical stages through registration.

• Develop and lead global regulatory strategies for rare disease and cell & gene therapy programs
• Provide regulatory leadership for INDs, BLAs, NDAs, and related lifecycle submissions
• Serve as a primary regulatory contact for the FDA and global health authorities
• Lead regulatory interactions including pre-IND, INTERACT, End-of-Phase, and advisory meetings
• Partner cross-functionally with Clinical, CMC, Nonclinical, Quality, and Program Management teams
• Support expedited development pathways (e.g., Orphan Drug, RMAT, Fast Track, Breakthrough Therapy)
• Monitor evolving regulatory guidance related to advanced therapies and assess impact to programs

• Bachelor’s degree in Life Sciences (Master’s or PhD preferred)
• 7–10+ years of regulatory affairs experience within biotech or pharmaceutical organizations
• Demonstrated experience in rare disease and/or cell & gene therapy development
• Strong knowledge of FDA and global regulatory requirements for advanced therapies
• Proven track record of leading regulatory submissions and health authority interactions
• Ability to operate both strategically and hands-on in a fast-paced environment

• Contribute to transformative therapies addressing high unmet medical needs
• Work alongside world-class scientific and clinical teams in the Boston biotech ecosystem
• Competitive compensation, comprehensive benefits, and career growth opportunities

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Apply now or reach out directly to learn more.