- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and… more
- GRAIL (Menlo Park, CA)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Abbott (Pleasanton, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, ... approval of new and modified products. + Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental… more
- Ascendis Pharma (Palo Alto, CA)
- …and/or PMP desired. + A minimum of 8 years of experience: 5 years in drug , biologic and/or combination products in Regulatory Affairs and 3 years of experience ... Management activities within the pharmaceutical and/or biotechnology industries. Orphan drug experience preferred. + Familiarity with Regulatory framework… more
- The Clorox Company (Pleasanton, CA)
- …a robust compliance program for our personal care and over-the-counter (OTC) drug products. This role independently leads regulatory activities, ensuring ... cosmetic and personal care space. + Strong knowledge of FDA regulations [e.g., The Food Drug and...drug regulations/monographs. + Proven ability to lead project regulatory strategies and influence cross-functional teams. + Excellent written… more
- Parexel (Sacramento, CA)
- …and/or drug -device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios * Represent CMC ... for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health...Health Canada (IND, NDA, DMF) * In-depth understanding of drug development, manufacturing processes, GMP, and regulatory … more
- Parexel (Sacramento, CA)
- …looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A ... At **Parexel** , we don't just support drug development-we help shape it. As a **Senior/Vice... regulatory applications. + Previous experience with a regulatory agency (such as the FDA or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Assess the impact of regulatory guidelines from the US Food and Drug Administration ( FDA ), European Medicines Agency (EMA), or the International Council for ... + Draft science-based articles intended for review, consideration, and presentation to regulatory agencies. ** Regulatory Intelligence Project (25%)** +… more
- Abbott (Alameda, CA)
- …other regulatory requirements. + Complies with applicable US Food and Drug Administration ( FDA ) and international regulatory requirements, Company ... working mothers, female executives, and scientists. **The Opportunity** This **Principal Regulatory Affairs Specialist - APAC** position will work on-site at our… more
- Stryker (Sacramento, CA)
- …desired **Knowledge / Competencies:** + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA , and International requirements + ... The **Senior Director, Regulatory Affairs** is a key strategist, responsible for...of 3 days. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance,… more