- 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …matters, including manufacturing site, device, and API considerations. + Collaborating with Regulatory Affairs to prepare ANDA submissions , patent ... Associate Director , Patent - Parsippany, NJ..., Patent, you'll collaborate with cross-functional teams, including R&D, regulatory affairs , and portfolio management, to ensure… 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