Senior Director of CMC Strategy
Job Summary
Providing strategic oversight and regulatory guidance, the full-time Senior Director of CMC Strategy will serve as a senior consultant to biotechnology and pharmaceutical clients while leading a team of regulatory professionals in a permanent remote role.
Key responsibilities
- Act as a senior regulatory consultant and strategic advisor for clients in the biotechnology and pharmaceutical sectors
- Offer subject matter expertise for CMC-related regulatory submissions and lifecycle management
- Lead and mentor a team of regulatory professionals, ensuring high performance and effective collaboration
Required qualifications
- 15+ years of experience in regulatory affairs, quality, CMC, or related fields
- Significant experience within a CRO, consulting, pharmaceutical, or biotechnology environment
- Strong knowledge of FDA regulations and global regulatory frameworks
- Proven success in leading high-performing regulatory teams
- Bachelor's degree in a scientific discipline; advanced degree preferred
Complete Job Description
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