- 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. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... Advertising Review(OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comment-Propose… 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
- AbbVie (Waltham, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description As an Associate Director of Regulatory Affairs in Chemistry, Manufacturing, and Controls ... Develops, implements, and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC. + Represents CMC… 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
- Gilead Sciences, Inc. (Foster City, CA)
- … CMC candidate to sit at our Foster City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for ... to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Associate Director , Global Regulatory Affairs ? The job is located in our King of ... is a hybrid position. You will report to the Director of Global Regulatory Affairs ....to Marketing Authorization (MA), and for any post MA submissions . + Contribute regional regulatory perspective to… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, ... field as applicable. **How you will contribute:** + The Associate Director will be responsible for increasingly...regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda… more
