Director, Regulatory CMC

Sci Pro is partnered with an exciting late-stage biotech that is seeking a Director, Regulatory CMC to join their team full-time. This role will lead the development and execution of global regulatory strategies and play a key role in guiding regulatory submissions, ensuring compliance throughout the product lifecycle, from development to commercialization.

We’re looking for a Regulatory CMC expert and strategic leader who thrives on solving complex challenges and navigating ambiguity. The ideal candidate will have a biologics background, experience leading HA interactions, global submission experience, and will excel in fast-paced, evolving environments.

This is a hybrid position with 2-3 days onsite in Boston, MA.

• Lead and implement CMC regulatory strategies across their late stage pipeline, including registration and lifecycle management.
• Prepare, review, and submit high-quality regulatory documentation (e.g., INDs, NDAs, amendments, supplements) aligned with global health authority requirements.
• Serve as the primary POC for CMC-focused Health Authority interactions
• Serve as a primary POC for CMC-related regulatory interactions with agencies such as FDA, EMA, PMDA, etc.
• Oversee submission readiness and post-submission activities
• Provide strategic input to cross-functional teams to ensure development plans align with regulatory expectations.

• Advanced degree (PhD, Pharm
  
  D, MS) with 10+ years, or Bachelor's degree with 10+ years, of relevant experience in Regulatory Affairs, with a strong focus on CMC.
• Proven experience with Phase 3 global programs
• Demonstrated success in authoring and compiling regulatory dossiers for global filings.