- BeOne Medicines (Emeryville, CA)
- **General Description:** The Senior Director , Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive ... regulatory strategies to ensure compliance with global health authorities....trends and metrics across the development pipeline. The Senior Director will guide and support the timely review of… more
- BeOne Medicines (Emeryville, CA)
- …The individual manages direct reports of 10+ and reports to global head of regulatory CMC. **Essential Functions of the job :** * Lead, develop, and optimize ... **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual… more
- Grifols Shared Services North America, Inc (Emeryville, CA)
- …2 years of experience. **Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in the United States (non-California), is ... hours per year. **For California:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in California, is $250,000.00- $340,000.00… more
- BeOne Medicines (Emeryville, CA)
- …while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the hematology ... **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… more
- BeOne Medicines (Emeryville, CA)
- …one or more Global Product Teams (GPTs). + Collaborate with R&D, Commercial, Medical Affairs , and Regulatory Affairs to ensure access-related insights and ... Description:** The position will report directly to the Executive Director (ED), Global Value, Access & Pricing (GVAP) Lead,...and communication. + Collaborate closely with Pricing, HEOR, Medical Affairs , Commercial, and Regulatory Affairs … more
- BeOne Medicines (Emeryville, CA)
- The Senior Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... sponsored studies, ensures the safety of patients. **Essential Functions of the Job :** + Accountable for oversight of benefit/risk safety profile of allocated… more
- BeOne Medicines (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... sponsored studies, ensures the safety of patients. **Essential Functions of the** ** Job :** + Accountable for oversight of benefit/risk safety profile of allocated… more
- Grifols Shared Services North America, Inc (Emeryville, CA)
- …regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve as program medical expert ... in more than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy relating to upcoming clinical trials,… more
- CSL Plasma (Fairfield, CA)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... ** Job Description Summary** Provides medical oversight to Medical...Director with the Food and Drug Administration (FDA). ** Job Description** + Serves as the primary physician for… more
- BeOne Medicines (Emeryville, CA)
- …Participate on additional product-specific core teams and initiatives. + Apply legal, regulatory , and compliance requirements to all Medical Affairs activities. ... in other activities as business needs evolve. **Essential Functions of the job :** As a medical information product specialist, perform the following duties for… more