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Associate Director, Regulatory Affairs, Philadelphia/Princeton/Horsham 15 years experience
Associate Director, Regulatory Affairs, Labeling led multiple teams to support ANDA approval and continued compliance with regulatory guidelines. Extensive negotiation with FDA reviewers to bring products to successful approval. Developed and led numerous pharma training sessions both internally and externally. Conducted company and global partner GMP and Quality Assurance audits. Successfully managed all aspects of a global drug safety system, ensured compliance for both in-house as well as 3rd parties.
Clinical Regulatory Affairs
About Me
Industry: |
Science & Biotech |
|---|---|
Occupation: |
Clinical Regulatory Affairs |
Education level: |
Bachelor |
Will Relocate: |
Yes |
