- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director , Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... is preferred and remote working possible **Location: Remote** **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices. All… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... and registration strategies within the US and Canada. The Director will also provide line management, people development, and...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- BeOne Medicines (San Mateo, CA)
- …or health-related discipline, with at least 12+ years of experience in regulatory affairs , in advertising/promotion, labeling or related discipline + and ... medical affairs , and marketing. + Provide advice on healthcare regulatory matters across business functions, including commercial, clinical development, medical … more
- Merck & Co. (South San Francisco, CA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be… more
- Stanford Health Care (Menlo Park, CA)
- …and resilience of healthcare systems? Join Stanford Health Care (SHC) as the Senior Director of the Office of Emergency Management (OEM) and play a pivotal role in ... patients is maintained during any type of disaster. As the Senior Director , you will lead the enterprise emergency management program, advancing operational… more
- Programmable Medicine Operatin (Redwood City, CA)
- …meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and ... our external contract manufacturing network while ensuring compliance with cGMP, regulatory requirements. This is an individual contributor, hands-on position. As… more
- BeOne Medicines (San Mateo, CA)
- …using clinical trial, real-world and post-marketing surveillance data. + Partner with regulatory affairs teams to establish and monitor competitive landscapes, ... functions to define KPIs, OKRs, metrics as pertained to pharmacovigilant and regulatory affairs , develop and implement role-based dashboards or analytical tools… more
- BeOne Medicines (San Mateo, CA)
- …Manager will collaborate cross-functionally with BeOne's internal audit operations, Regulatory Affairs , Quality, Pharmacovigilance, Safety, Clinical, CMC and ... Regulatory Compliance Readiness will report to the Senior Director of Regulatory Compliance and play a...Framework, strengthening inspection readiness and proactive risk oversight across Regulatory Affairs and Regulatory Operations.… 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)
- **General Description:** The Senior Director , North America Patient Advocacy, will lead and execute regional strategy focused on patient access initiatives that ... into actionable strategies to inform company payer, policymaker, and regulatory engagement in the US and Canada. + Partner...and Canada. + Partner cross-functionally with Market Access, Government Affairs , Medical Affairs , and Sales to align… more
- BeOne Medicines (San Mateo, CA)
- …commercial and medical organization including Medical and Value Organization (MVO), Medical Affairs , Brand Marketing, Legal & Regulatory , and our Global ... **General Description:** The Director , Digital Marketing, Market Access Strategic Marketing will lead the digital marketing efforts, including setting the strategic… more
- BeOne Medicines (San Mateo, CA)
- …prepare for key competitive events and market dynamics. + Partner with Medical Affairs , Regulatory , Access, and marketing teams to craft responsive and proactive ... most importantly, share our passionate interest in fighting cancer. As the Director , Global Commercial, Sonrotoclax, you will lead global initiatives related to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As a Director , Virology Global Regulatory Affairs , you will develop and ... Teams or other Regulatory Project Teams and represent Global Regulatory Affairs on cross-functional core and sub-teams including Project Strategy Teams. You… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** Specific Education & Experience Requirements: + 10+ years of experience in Regulatory Affairs or other relevant industry experience. + Degree in a ... submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a scientific or technical discipline required (advanced degree preferred) - with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ ... enterprise platforms. + Prioritize use cases across submission acceleration, regulatory intelligence, authoring automation, and knowledge reuse. + Translate… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead is seeking a dynamic and strategic leader to serve as Executive Director , Global Therapeutic Area Communications and Advocacy, HIV. This pivotal role is ... leads in Global Commercial Product Strategy & Operations, Clinical Development, Medical Affairs and Government Affairs , and engages colleagues across Public … more
- Gilead Sciences, Inc. (Foster City, CA)
- …Medical Affairs , US Commercial, US Government Affairs and Policy, US Public Affairs , US Regulatory , and US legal and compliance + Represent US data gaps ... countries worldwide, with headquarters in Foster City, California. **Job Overview:** The Executive Director (ED) USMA Strategy - Liver and Covid is a key member of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of the HIV Treatment Strategy team. We are looking for a highly motivated Medical Affairs Senior Director who has a strong background in HIV Treatment. They will ... and publication plans to commercial stakeholders. + Collaborate with Legal, Regulatory , Clinical, Public/Government Affairs , and other partner functions to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The ** Director , USMA Digital Strategy** will play a critical role in the developing ... and executing the US Medical Affairs digital strategy. The individual will lead the vision,...Medical for customer experience, digital strategy, internal and external regulatory and governance processes, and systems related to digital.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help develop the TA's ... Specific Education & Experience Requirements: + 12+ years of experience in Regulatory Affairs or other relevant industry experience + Degree in a scientific… more
