- Gilead Sciences, Inc. (Foster City, CA)
- …BA/BS with 10+ years' relevant experience. + 4+ years' experience in prescription drug labeling. + Significant regulatory experience in the biopharma industry is ... their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global … more
- Kelly Services (Thousand Oaks, CA)
- …research environment. + Stay abreast of the latest scientific advances in CNS drug delivery, bioanalysis, and regulatory frameworks to ensure research practices ... Senior Scientist/Principal Scientist - CNS Drug Delivery **Job Summary:** Our client is a...join a highly dynamic team dedicated to advancing CNS drug delivery technologies. We are seeking a Senior Scientist/Principal… more
- MAAC (Metropolitan Area Advisory Committee) (Chula Vista, CA)
- …hours and/or units (CEH or CEU) as determined by the Department of Alcohol and Drug Programs and/or other regulatory agencies. + Performs other related duties as ... sessions and workshops for residents on a variety of subjects, including drug and alcohol education, domestic violence, psychological and physiological effects of… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription … more
- Ascendis Pharma (Palo Alto, CA)
- …developing regulatory affairs strategies + Preferred experience with a drug device combination products + Extensive regulatory experience including IND/CTA, ... in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head...intellect, and an understanding of the business aspects of drug development. At a personal level, the company is… more
- Merck (South San Francisco, CA)
- …and model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams. + Collaborate with other functional areas, as ... of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia. + Educational background in… more
- Gilead Sciences, Inc. (Foster City, CA)
- … drug labeling. + Significant experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, ... Strong track record of successes working and negotiating with regulatory authorities. + Global prescription drug label...negotiating with regulatory authorities. + Global prescription drug label experience, US, EU, and potentially more. +… 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
- Bristol Myers Squibb (San Diego, CA)
- …clinical development leader; with greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong ... organization dedicated to the effective design and execution of drug development. Clinical Development drives clinical development strategy, design, execution,… more