- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with ... related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. +… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... development, regulatory , and registration strategies. + The Director , Global Regulatory Lead supporting...and labeling changes. + Maintains awareness of global regulatory environment and assesses impact of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Senior Director , Regulatory Management, WW IPD ("Sr Director Regulatory WWIPD") and submissions, in support of global marketing of company products ... initiatives and develop, under the oversight of the Sr Director Regulatory WWIPD, Regulatory strategies...medical-related field + Successful track record with US and global regulatory bodies + Minimum of nine… more
- Sumitomo Pharma (Sacramento, CA)
- … Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- BeOne Medicines (Emeryville, CA)
- …expedite approvals of product and labeling changes + Maintains awareness of global regulatory environment and assess impact of changes on business and ... **General Description:** The Director , Regulatory Affairs will be responsible...line with business objectives, and in coordination with the global regulatory leader and key internal stakeholders.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …become your best self. Become a **maker of possible** with us. **The Associate Director of Regulatory Affairs** will provide regulatory support for medical ... activities, developing and maintaining documentation for compliance programs such as labeling , promotional material review, and other regulatory requirements.… more
- GRAIL (Menlo Park, CA)
- … plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing ... North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **Executive Director , Global Clinical Supply Chain (GCSC)** **KEY RESPONSIBILITIES:** ... Executive Director , Global Clinical Supply Chain is responsible for leading clinical...the long-term vision of optimal supply chain strategies including labeling and distribution activities. + Responsible for risk balancing… more
- BeOne Medicines (San Mateo, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... multi-indication) and creates and maintains a single interpretation of global safety data for developmental and marketed products. With the support of Safety… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … submission content (510(k), Technical Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non-Medical ... self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to...PowerPoint, Teams + Project Management experience + Knowledge of global Regulatory Affairs requirements, regulations and standards… more