- Merck & Co. (Rahway, NJ)
- …assessment ( RA ), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.).Adaptability and agility to prioritize ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions . -Under the general scientific and administrative… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory ... strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and… more
- Merck (Rahway, NJ)
- …risk assessment ( RA ), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.). + Adaptability and agility to ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions . Under the general scientific and administrative… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title:** Regulatory Strategist ( Associate Director ) **Location** : Bridgewater, NJ / Swiftwater, PA **About the Job** Are you ready to shape the future ... to the Flu Global Regulatory Lead. The Regulatory Strategist ( Associate Director ) will...industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global). +… more
