- J&J Family of Companies (Santa Clara, CA)
- …more at https://www.jnj.com/medtech We are searching for the best talent for a ** Director , Regulatory Affairs ** to support our **Monarch robotics** platform. ... be available on a case-by-case basis. **Purpose** : The Director , Regulatory Affairs will engage...new and revised engineering protocols and reports, and product labeling . **You will be responsible for** : + Develop… 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
- 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 Associate Director , Regulatory Affairs will be responsible for developing, implementing, and advising North America (NA) ... 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
- Actalent (South San Francisco, CA)
- Job Title: Director , Regulatory Advertising, Promotion & Labeling (Part Time) Job Description The Regulatory Labeling Manager serves as a vital ... ensure consistent, accurate, and compliant messaging across channels. + Provide strategic regulatory labeling guidance to cross-functional teams. + Oversee the… 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …with affiliate MI and relevant internal partners who may include medical affairs , development, regulatory , global patient safety and operations, commercial, to ... improving the lives of patients for generations to come. As a **Assoc Director , Medical Information** , at Gilead you will **Responsibilities** + Responds to… more
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