Senior Director of Quality
Job Summary
Providing strategic CMC and quality regulatory guidance, the remote Senior Director of Quality will lead global regulatory strategies for biotechnology and pharmaceutical clients, oversee submission preparations, and mentor regulatory professionals while supporting business growth initiatives.
Key responsibilities:
- Lead global CMC regulatory strategies for development, registration, and post-approval programs
- Serve as a trusted advisor to clients on regulatory pathways and submission planning
- Oversee the preparation and review of INDs, amendments, and global filings
Required qualifications:
- Bachelor's degree in a scientific discipline required; advanced degree preferred
- 15+ years of experience in Regulatory Affairs, CMC, Quality, or related fields
- Extensive knowledge of FDA regulations and global regulatory requirements
- Experience supporting biologics, small molecules, and novel therapeutic platforms
- Proven leadership experience managing regulatory teams and client interactions
Complete Job Description
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