- Regeneron Pharmaceuticals (Tarrytown, NY)
- …for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams and ... typical day might include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global...policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... Scientist (Associate Director ) is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects of clinical phase through market product… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Bristol Myers Squibb (Madison, NJ)
- …Field Medical + Clinical Research and Development + Statistics + Translational Research + Regulatory Affairs including CMC - Regulatory + Manufacturing and ... and other departments, including Commercial, Clinical Research and Development, Regulatory Affairs , Managed Care, Pharmacovigilance, Market Access, Statistics,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …independently, as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC /Formulations, Biostatistics, Legal, ... key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Director will provide input to the… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …independently, as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC /Formulations, Biostatistics, Legal, ... documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The Sr. Director , Clinical Development will… more
- Organon & Co. (Jersey City, NJ)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... position can be 100% remote in the US** The Director , Translational Medicine and Early Development (TMED) Lead will...are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans.… more
- AbbVie (Florham Park, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is ... responsible for the management of global regulatory leads with product and disease state expertise for...+ Strong experience working with multiple functions (Ad/Promo, Labeling, CMC , devices, Clinical development, etc.) and cross functional teams… more