- BeiGene (Emeryville, CA)
- The Executive Director , Solid Tumor North America Lead will be responsible for managing a team of NA leaders within the solid tumor franchise and supporting the ... met while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the solid tumor… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Job Overview:** The Executive Director (ED) USMA Strategy - HIV Treatment is a key ... , US Commercial, US Government Affairs and Policy, US Public Affairs , US Regulatory , and US legal and compliance. + Represent US data gaps and research… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... Division. As a manager, the function of an Associate Director Regulatory Affairs , APAC (Asia...comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... area or law is helpful. + Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + Previous experience with 510k / PMA / DeNovo… more
- Gilead Sciences, Inc. (Foster City, CA)
- …benefit from them, regardless of where they live or their economic status. ** Director , Therapeutic Area Strategy - Virology, Government Affairs ** This newly ... of projects in support of our growing virology portfolio within Government Affairs (GA). GA is responsible for establishing comprehensive strategies that aim to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Diseases co. Gilead is a patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and ... include but are not limited to: + Partner with stakeholders (eg, Medical Affairs , Business Conduct, Development, Regulatory Affairs , Legal and Commercial)… more
- BeiGene (Emeryville, CA)
- The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory strategies ... are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross-functional influence and acts as an… more
- BeiGene (Emeryville, CA)
- **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible for managing a team of NA leaders within the Hematology ... while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the hematology… more
- BeiGene (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... approved BeiGene products + Actively leads Development and Medical Affairs product teams in the identification of, and handling...depending on the program / portfolio being led. The Executive Medical Director serves as Product Safety… more
- BeiGene (Emeryville, CA)
- **General Description:** The Executive Director for Manufacturing Operations Business Development will be responsible for identifying, evaluating, and developing ... Work closely with internal teams including Manufacturing Operations, Quality Assurance, Regulatory Affairs , Strategy and Corporate Development, and Project… more
- Veterans Affairs, Veterans Health Administration (San Francisco, CA)
- Summary The Health System Specialist serves as the Executive Assistant to the Deputy Director at the SFVAHCS. The Health Systems Specialist provides guidance, ... and accurate manner and provides final recommendations to the Deputy Director . Develops comprehensive reports, studies, business plans, and presentations for the… more
- AbbVie (South San Francisco, CA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management. Proactively informs AST and… more
- Vera Therapeutics (Brisbane, CA)
- …scientifically accurate manner. * Work with functional representatives such as regulatory affairs , clinical and nonclinical development, clinical pharmacology, ... Job Title: Associate Director , Medical Writing Location: Brisbane, CA About Us:... regulatory and program timelines in coordination with regulatory affairs , project management, and cross-functional leadership.… more
- BeiGene (Emeryville, CA)
- …partnerships with key business stakeholders, including Clinical Operations, Clinical Development, Regulatory Affairs , Data Management, Biostats, GPS, RBQM, etc. ... **General Description:** The Associate Director of R&D Quality Systems, Strategy, and Excellence (Strategy & Innovation) is responsible for leading initiatives that… more
- Gilead Sciences, Inc. (Foster City, CA)
- …as point-of-contact for internal stakeholders, including Brand, Managed Markets, Government Affairs , Finance, Legal and executive leadership, on all business ... Join Gilead and help create possible, together. **Job Description** As the Director of Trade Strategy within Gilead's US Managed Markets, Cross-Portfolio team, you… more
- Abbott (Alameda, CA)
- …Cross-Functional Collaboration: Collaborating with other departments such as R&D, Manufacturing, Regulatory Affairs , Operations and Engineering to ensure quality ... diversity, working mothers, female executives, and scientists. **The Opportunity** The Director , Quality Engineering will provide oversight and management for the… more
- Vera Therapeutics (Brisbane, CA)
- …product development, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs , to ensure quality and compliance throughout ... Title: Associate Director , Quality Assurance - Medical Device/Combination Product Location:...cross-functional teams to ensure that the combination product meets regulatory standards, are safe and effective for patient use.… more
- Vera Therapeutics (Brisbane, CA)
- …team. The Associate Director , Quality Assurance will report to the SVP, Regulatory Affairs & Quality Assurance and will be responsible for developing and ... Title: Associate Director , Quality Assurance Location: Brisbane, CA About Us:...per industry standards. * Assess and assure quality and regulatory compliance related to GCPs, pharmacovigilance, GLPs, and other… more
- Vera Therapeutics (Brisbane, CA)
- …complete regulatory content that meets current regional requirements. * Represent Regulatory Affairs (Clinical and CMC) on cross-functional project teams. * ... team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be...field and 6+ years of relevant experience and demonstrated Regulatory Affairs experience commensurate with the role.… more
- BeiGene (Emeryville, CA)
- …and our commitment to serve patients wherever they reside. As the Senior Director , Global Commercial Leader, Lung Cancer Disease Area Strategy (DAS) and Pipeline, ... that meets the needs of various Regional stakeholders including Regulatory and Reimbursement bodies around the globe. This role...Cancer. Present key updates as needed to Project and Executive teams. + In close coordination with Early Development… more