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Associate Director, Global Regulatory Science
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$150
- Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
- BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
- 5+ years of experience in Biologics focused Regulatory CMC
- Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions,
- Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM),
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