- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. Director of Regulatory Affairs is responsible for developing and implementing ... Director , Regulatory Management, WW IPD ("Sr Director Regulatory WWIPD") and submissions, in support...with US and international laws and regulations + Manage Regulatory Affairs platform and leads a team… more
- Sumitomo Pharma (Sacramento, CA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and become your best self. Become a **maker of possible** with us. **The Associate Director of Regulatory Affairs ** will provide regulatory support for ... regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations including… more
- GRAIL (Menlo Park, CA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... issues and to expedite approvals of product and labeling changes + Maintains awareness of global regulatory...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- 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 the ... Preferred **Knowledge and skills** + Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required + Solid… more
- BeOne Medicines (San Mateo, CA)
- …are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as ... **General Description** **_:_** + The Director , Global Regulatory Lead, will be...candidates will have experience working as a lead in Regulatory Affairs across two or more major… 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 ... developmental and approved BeiGene products + Actively leads Development and Medical Affairs product teams in the identification of, and handling of product safety… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow, and become your best self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior Director ... Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of...product development, sustaining, and end of life activities. The Director will oversee the hiring, training, and career development… more
- Ascendis Pharma (Palo Alto, CA)
- … labeling , investigator brochures, protocols, informed consent forms, and regulatory submissions + Collaborate with internal and external stakeholders on ... role The role of Program Safety Lead is a director level position here at Ascendis and this Lead...pharmacovigilance agreements, audits, and regulatory inspections + Monitor industry best practices and evolving… more