Senior Manager Regulatory Affairs

Senior Manager, Regulatory Affairs – Gene Therapy (Boston, MA)

We are a rapidly growing biotech company based in Boston, dedicated to developing breakthrough gene therapies for rare and orphan diseases. Our mission is to transform patients’ lives by advancing innovative therapies from early development through commercialization.

We are seeking a Senior Manager, Regulatory Affairs to join our Boston office and lead regulatory strategy, submissions, and interactions for our gene therapy programs. This role requires hands‑on experience in regulatory submissions, cross‑functional collaboration, and navigating complex pathways with the FDA and global health authorities.

• Lead development and execution of global regulatory strategies for gene therapy programs.
• Prepare, review, and submit regulatory documents including INDs, BLAs, and amendments.
• Serve as primary point of contact for FDA, EMA, and other global regulatory agencies.
• Collaborate with clinical, CMC, and manufacturing teams to ensure regulatory alignment across programs.
• Support regulatory lifecycle management, including post‑approval submissions and labeling activities.
• Provide strategic guidance on regulatory compliance, risk management, and emerging regulatory trends.
• Mentor and support junior regulatory staff.

• Bachelor’s degree in life sciences, pharmacy, or related field (advanced degree preferred).
• 8+ years of experience in Regulatory Affairs in biotech, with at least 4 years in gene therapy, rare disease, or advanced biologics.
• Hands‑on experience with IND, BLA, and global submissions.
• Strong knowledge of FDA, EMA, PMDA, and other international regulatory requirements.
• Experience with eCTD publishing, Veeva Vault RIM, and other submission platforms.
• Excellent communication, project management, and cross‑functional collaboration skills.

• Be part of a pioneering gene therapy company making a real impact in rare disease.
• Collaborate with passionate experts across clinical, CMC, and regulatory teams.
• Competitive salary, comprehensive benefits, and professional growth opportunities.