- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs , Regulatory Strategy to be a ... part of our Global Regulatory Affairs organization.In this role, you will...to global regulatory lead to ensure optimal regulatory success. Represent US RA in the… more
- 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
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for Associate Director , RA Submissions . The position can be located on-site/hybrid in the US ... with dossier level publishing partners to achieve production of regulatory submissions that conform to regional and...equivalent experience in a related field (Pharmacy, Life Sciences, Regulatory Affairs , etc.) + A minimum of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and Promotion ( RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across ... biologic products. + Significant experience leading development and execution of regulatory submissions of promotional materials for marketed prescription drug… 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
- 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
- ACLD (Bethpage, NY)
- …are submitted in a timely manner. + Act as a liaison ACLD's Regulatory Affairs to ensure timely and accurate submissions of all Corrective Action Plans. + ... you will a ct as a support to the Associate Director to ensure that all programs...highest quality. Ensure that all assigned programs meet all regulatory requirements. Assist in training of residential staff as… more
