- Lilly (Indianapolis, IN)
- …has a diverse and expanding portfolio of ADCs that require thorough drug -linker process development and regulatory submission strategies, often with compressed ... accelerate the development of lifesaving new medicines for our patients. Our antibody- drug conjugate (ADC) team seeks to perform innovative and cutting-edge research… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Demonstrated success of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization ... of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device...deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process. + RAC… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Outlook, Word, PowerPoint, and Excel. + Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy ... **Description** The Regulatory Affairs Fellow - Advertising and Promotion is...build a foundational understanding of compliance with the Food Drug and Cosmetic Act (FDCA), FDA Guidance, and the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as evolving regulatory trends and developments for their impact on drug development activities and on existing development strategies. + Share new/novel "on the ... Outlook, Word, PowerPoint, and Excel. + Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy… more
- BeOne Medicines (San Mateo, CA)
- …with the FDA and Health Canada as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals ... **General Description:** The Director, Regulatory Affairs will be responsible for developing, implementing,...both small molecules and biologics + Thorough understanding of drug development process and the pharmaceutical industry and healthcare… 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 Associate Director, Regulatory Affairs, you will be responsible for leading...device project activities and new product development in Advanced Drug Development Delivery platform. You will be the primary… 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
- 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
- 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
- Boehringer Ingelheim (Ridgefield, CT)
- …Outlook, Word, PowerPoint, and Excel. * Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy ... **Description** The Regulatory Affairs Labeling Operations Fellowship is designed to...Fellowship is designed to provide pharmacists with exposure to regulatory requirements for US package and product labeling. The… more