- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global regulatory ... Externally, the individual will interface with business partners regarding global development, regulatory , and registration strategies. + The Director , Global … more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global clinical… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Senior Director of Global Regulatory Project Management is a pivotal leadership role responsible for overseeing and driving the ... successful execution of regulatory strategies and projects in a dynamic and highly...BeOne's Senior Management. This role blends deep expertise in regulatory affairs with best-in-class project management skills to ensure… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …can continue making a positive impact in the cancer field. The Associate Director , Regulatory Affairs, Advertising and Promotion is responsible for providing ... therapy. The Associate Director will report to a Senior Director in Regulatory Affairs, Advertising and Promotion. + Review of promotional, corporate, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a critical strategic...acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information… more
- GRAIL (Menlo Park, CA)
- …For more information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership with key internal ... including Multi-Cancer Early Detection (MCED). The position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements,… more
- United Therapeutics (Sacramento, CA)
- …like lungs, pancreases and hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory pathways, managing documentation and ... timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Are you looking to fundamentally… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and ... regulatory expectations. Champion regulatory innovation and novel approaches to accelerate development and approval timelines. Provide guidance to PDM Teams and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH requirements, ... and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively collaborates… more
- BeOne Medicines (San Mateo, CA)
- **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent ... responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive timelines… more