- 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
- 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …management (eg, xEVMPD, IDMP). + Ability to apply a broad functional knowledge of Regulatory Affairs ( RA ) and Chemistry, Manufacturing, and Controls (CMC) ... innovative opportunities to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - ... Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners..., to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory… 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
