Senior Director of Quality
Job Summary
To support a leading regulatory consulting organization, the remote Senior Director of Quality will provide strategic CMC and quality regulatory guidance to biotechnology and pharmaceutical clients, overseeing global regulatory strategies 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 to clients on regulatory pathways and health authority interactions
- Oversee the preparation and review of INDs, amendments, 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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