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, overseeing submissions and ensuring compliance throughout the product lifecycle.
Key responsibilities
- Lead global CMC regulatory strategies for development, registration, and post-approval programs
- Serve as a trusted advisor on regulatory pathways and submission planning for clients
- Oversee the preparation and review of INDs, global filings, and lifecycle management submissions
Required qualifications
- Bachelor's degree in a scientific discipline; 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 engagements
Complete Job Description
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