- J&J Family of Companies (Raritan, NJ)
- …during the APPE may include, but are not limited to: + Support the management of regulatory or drug development issues + Gain knowledge of the US FDA regulations ... the Advanced Pharmacy Practice Experience (APPE) program in 2025 to support Global Regulatory Affairs (GRA). The APPE rotation will be based remotely. There are many… more
- Boehringer Ingelheim (Ridgefield, CT)
- …* Determine "best practices" to seamless Research to Development transitions of nominated drug candidates to Regulatory Toxicology and R&D Drug Development ... for internal (Research, Development, Medicine, Regulatory ) and external regulatory interactions involving investigative toxicology de-risking of drug … more
- BeOne Medicines (San Mateo, CA)
- …to negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals ... stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of...in the oncology therapeutic area. + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… more
- BeOne Medicines (San Mateo, CA)
- …with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite ... **General Description** **_:_** + The Director, Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory … more
- BeOne Medicines (Cambridge, MA)
- …+ Liaises and negotiates with FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite ... BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director, Regulatory Affairs in Cambridge, MA, USA: **Job Duties:** + Provides high level regulatory strategic and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …within the pharmaceutical or medical device industries, ideally with expertise in drug -device combination products; experience in regulatory and/or R&D, quality ... **Job Description Summary** As Regulatory Affairs Associate Director, you will be responsible...device project activities and new product development in Advanced Drug Development Delivery platform. You will be the primary… more
- Rhythm Pharmaceuticals (Boston, MA)
- …+ BS or graduate degree in life sciences preferred + 8+ years of Regulatory Affairs experience in drug development and product registration activities within the ... to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development… more
- Norstella (Columbia, SC)
- …and healthcare service providers, including the top 10 global pharma and CROs. From drug and device discovery and development to regulatory approval, and from ... enabling them to cut through the clutter and make sense of changing drug development, regulatory and competitive landscapes. Now, Citeline is proud to be a part… more
- Danaher Corporation (Fargo, ND)
- …previous experience in: + Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines Aldevron, ... and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron's Fargo, ND… more
- Bausch Health (Bridgewater, NJ)
- …labeling/ regulatory experience. + Thorough understanding of scientific principals and regulatory systems, relevant to drug development + Experience writing ... drive our collective progress and impact. The Global Labeling Director provides regulatory expertise and guidance for labeling strategy, to deliver high quality… more