Senior Director of Quality
Job Summary
To provide strategic CMC and quality regulatory guidance, the remote Senior Director of Quality will lead global regulatory strategies, serve as a trusted advisor to clients, and oversee the preparation and review of regulatory submissions while mentoring regulatory professionals.
Key responsibilities
- Lead global CMC regulatory strategies for development, registration, and post-approval programs
- Serve as a trusted advisor on regulatory pathways, submission planning, 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, biotechnology, or pharmaceuticals
- 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 serving as a client-facing strategic advisor
Complete Job Description
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