- Gilead Sciences, Inc. (Foster City, CA)
- …with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is responsible for leading ... in Gilead's global portfolio of biological products in CMC Regulatory Affairs . This position will provide leadership...by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and… more
- Stanford Health Care (Palo Alto, CA)
- …Brief Overview** The Senior Director of Quality Management and Regulatory Affairs is responsible for the strategic planning, oversight and direction of ... accreditation, regulatory , and licensing across Stanford Health Care. This includes... for Quality, Patient Safety & Infection Prevention, the Senior Director collaborates with cross-functional leaders and… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory ... workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …include but are not limited to: + Partner with stakeholders (eg, Medical Affairs , Business Conduct, Development, Regulatory Affairs , Legal and Commercial) ... Gilead is a patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and Analytics this… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Primary Biliary Cholangitis (PBC). This role is based in Foster City, CA. Reporting to the Senior Director US Medical Affairs (USMA) Liver - PBC, this ... needed to support field Medical Scientists + Supports the Senior Director in developing and execute the...projects. + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to lead… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Affairs Associate Director , HIV Prevention, will report directly to the Senior Director for US HIV Prevention. The successful candidate will contribute to ... Description** We are looking for a highly motivated Medical Affairs Associate Director who is passionate about...trainings + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to support… more
- Ascendis Pharma (Palo Alto, CA)
- … information to project teams. + Works independently with directional support from a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a ... to all aspects of the business, from drug development to marketing. The Manager, Regulatory Affairs will be responsible for supporting and developing global … more
- Abbott (Alameda, CA)
- …data sets. + Facilitates communication between Sales and Marketing, R&D, Clinical, Regulatory Affairs , Quality, Risk Management, and Project Management. + ... numerous analytes in a healthcare setting. We have an opportunity for a Senior Scientific Affairs Specialist. This position will work closely within the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES ... The Sr Director , Analytical Regulatory Science, is responsible for supervising a team of...The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at… more
- Gilead Sciences, Inc. (Foster City, CA)
- …areas, including Commercial, Marketing, Clinical Research, Pharmacovigilance and Epidemiology, Public Affairs , Government Affairs , Regulatory , and Legal + ... We have an exciting opportunity within the US Medical Affairs team for an Intern in PBC within the...PBC within the Liver Team. Reporting to the Sr Director of USMA PBC Strategy, this role will be… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Business Operations believe talented people deserve a ... and impactful! The Business Operational Excellence function works across Gilead Global Regulatory Affairs (GRA) to provide the framework for GRA process… more
- BeiGene (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
- BeiGene (San Mateo, 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
- Merck (South San Francisco, CA)
- …execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating ... **Job Description** The ** Senior Clinical Director (Sr. Principal Scientist)**...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- BeiGene (San Mateo, CA)
- …cancer and our commitment to serve patients wherever they reside. As the Senior Director , Global Commercial Leader, Breast Cancer Disease Area Strategy (DAS) ... package that meets the needs of various Regional stakeholders including Regulatory and Reimbursement bodies around the globe. This role requires comprehensive… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Purification Process Development - Pivotal & Commercial ... Biologics** The Senior Director of Purification Process Development for...strategy in partnership with organizations across Technical Development, Quality, Regulatory Affairs CMC, and Manufacturing. + Lead… more
- Allogene (South San Francisco, CA)
- …About the role: Allogene is seeking an experienced Rheumatologist to join us as a Medical Director / Senior Medical Director for our allogeneic CAR T cell ... is a key organizational position with high visibility to senior leadership. This position is based out of our...Operations to expedite execution of clinical trials * Support regulatory activities, medical affairs , and payer engagements;… more
- AbbVie (South San Francisco, CA)
- …The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to ... will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs. Responsibilities: + Understanding and… more
- Pfizer (South San Francisco, CA)
- …as appropriate working with Clinical Affairs Lead, Medical/Scientific Affairs Lead and Partner representatives. + Influences management/ senior management ... discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings. + Represents Vaccine Clinical Affairs and may take… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Affairs , Value and Access, Clinical Development, Competitive Intelligence, Legal, and Regulatory Affairs ). + Serve as Commercialization Team Leader, working ... strategies and partnering with Governmental Affairs , Public Affairs , Medical Affairs , R&D, V&A, GDSI, Legal and Regulatory partners + Prior experience in… more