Provide strategic Regulatory CMC leadership across Generate’s biologics portfolio, ensuring cohesive, phase-appropriate global strategies that support late-stage (Phase 3) development, registration, and lifecycle management
Job Summary
Provide strategic Regulatory CMC leadership across Generate’s biologics portfolio, ensuring cohesive, phase-appropriate global strategies that support late-stage (Phase 3) development, registration, and lifecycle management.
Serve as the primary company representative for CMC-focused Health Authority interactions, leading strategy development, preparation of briefing materials, and direct engagement with agencies to clearly communicate company positions and achieve successful outcomes.
Stay current with evolving global CMC regulations and guidances, translating new requirements into practical internal strategies to maintain compliance and accelerate development.
Matching Summary
Provide strategic Regulatory CMC leadership across Generate’s biologics portfolio, ensuring cohesive, phase-appropriate global strategies that support late-stage (Phase 3) development, registration, and lifecycle management.
Salary
Base: $186,000 - $279,000 USD; Bonus/Equity: eligible for an annual bonus, equity compensation; Benefits: competitive benefits package
Skills & Requirements
Must-have
Global regulatory strategy
CMC regulatory submissions
Health Authority interactions
Biologics manufacturing and quality systems
Phase 3 development and registration
Nice-to-have
Experience with novel modalities
Fast-paced innovative organization
Cross-functional collaboration
Key Requirements
10+ years of Regulatory Affairs experience
Significant expertise in Regulatory CMC
Proven experience supporting Phase 3 global development programs