- 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 (Valencia, CA)
- …regulatory affairs + Knowledge of FDA medical devices and/or pharmaceutical ( drug ) registrations. + Familiarity with regulatory submissions and performing ... ** Regulatory Affairs Specialist - Valencia, CA** Kelly(R) Science...Valencia, CA** Kelly(R) Science & Clinical is seeking a Regulatory Specialist for a temporary, long-term position (approx. 1… 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
- 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)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... or a related field + At least 10 years of discovery/ drug development/ regulatory experience + Deep expertise in pharmacometrics (eg, population PK and… 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
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory packages **.** + Lead **clinical ... + Interact cross-functionally across other key disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and experience in one or more of the following areas: + Experience in drug development, authoring documents for regulatory authorities + Deep understanding of ... is to design and conduct or monitor experiments to understand the metabolism and drug - drug interaction (DDI) properties of drug candidates, particularly the… 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