- 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful ... Abilities: + Ten years previous experience in global regulatory affairs and regulatory submissions for drugs, preferably experience in oncology. + Five… 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