Associate Director / Director, Regulatory Affairs - CMC

Highlights

• Lead global CMC regulatory strategy across clinical-stage development programs.
• Author Module 3 content for INDs, CTAs and health authority responses.
• Represent company in CMC-focused FDA interactions and briefing packages.

What they offer

• Company paid healthcare
• Flexible spending accounts
• Voluntary life insurance
• 401(k) matching
• Uncapped vacation
• Onsite gym and dining

Ideal candidate

Experienced CMC regulatory leader who thrives in fast-paced biotech and partners cross-functionally to advance novel medicines. Detail-oriented problem-solver passionate about AI-driven discovery and high-quality global strategy.

Requirements

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, chemical engineering or related discipline
• 8+ years pharma/biotech experience for Associate Director and 10+ years for Director including CMC regulatory affairs
• Experience developing CMC regulatory strategy and preparing Module 3 content for clinical-stage submissions
• Strong knowledge of global CMC requirements including FDA and ICH expectations
• Excellent scientific writing, communication, collaboration and project management skills