- Pliantrx (San Francisco, CA)
- Director , Regulatory Affairs and Quality Project ManagementPliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and ... patients, and families impacted by fibrotic diseases.DescriptionThe Director of Regulatory Affairs and Quality Project Management must thrive in a… more
- BridgeBio Pharma (San Francisco, CA)
- Director /Sr. Director , Regulatory Affairs Calcilytix San Francisco, CA/Hybrid Regulatory Affairs Calcilytix Therapeutics, an affiliate of ... and may interact with health authorities. In conjunction with regulatory affairs leadership, they will develop strong...and present guidelines and SOPs as needed to support high- quality submissions and assure adherence to regulatory … more
- Biolink360 (San Francisco, CA)
- … Affairs - San FranciscoWe are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. ... to NPD.Provide direction and guidance to project teams to execute complex regulatory affairs projects & initiatives.Prepare documentation packages for submission… more
- Kyverna Therapeutics, Inc. (Emeryville, CA)
- …how autoimmune diseases are treated.Kyverna is seeking an experienced and passionate Associate Director , CMC Regulatory Affairs with a strong background in ... looking for candidates with 3-5+ years of direct CMC Regulatory Affairs experience who are eager to...submissions and interactions with health authorities.Author and/or review high quality CMC sections for global regulatory submissions… more
- Vir Biotechnology, Inc. (San Francisco, CA)
- …work closely with the Technical Operations (CMC) functional groups and Regulatory Affairs department to plan and author high quality regulatory ... Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all assigned products… more
- Biolink360 (San Francisco, CA)
- Senior Regulatory Affairs Specialist - Remote Based - West CoastReports to: Global Regulatory Affairs DirectorSalary Range: 140-170KLocation: Remote ... travel to West Coast, must reside in Pacific or Mountain time zone.This Senior Regulatory Affairs Specialist will have an opportunity to work on new to… more
- Abdera Therapeutics (San Francisco, CA)
- …global regulations, and guidance.Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.Support in the preparation ... of the Regulatory Affairs department budget.Qualifications, Education & ExperienceBachelor's...create the most efficient and effective methods to deliver quality clinical trial services.Willingness to collaborate with the team… more
- Pendulum (San Francisco, CA)
- …the quality function at Pendulum. This role will report to the VP of Regulatory Affairs and Quality . What You'll Do:Ensure cGMP compliance against 21 CFR ... with internal business partners (including Manufacturing, Supply Chain, Process Development, Regulatory Affairs ) to deliver the innovation pipeline and meet… more
- Pendulum (TM) (San Francisco, CA)
- …the quality function at Pendulum. This role will report to the VP of Regulatory Affairs and Quality . What You'll Do: Ensure cGMP compliance against 21 ... with internal business partners (including Manufacturing, Supply Chain, Process Development, Regulatory Affairs ) to deliver the innovation pipeline and meet… more
- University of California, Berkeley (Berkeley, CA)
- Executive Director (0475U) 71269About BerkeleyAt the University of California, Berkeley, we are committed to creating a community that fosters equity of experience ... to our mission.For more information, visit http://ehs.berkeley.edu.Position SummaryThe Executive Director of the Office of Environment, Health & Safety (EH&S)… more
- Pinterest (San Francisco, CA)
- …managing high-profile escalations while maintaining composure and strong decision quality .Strong understanding of regulatory and industry trends and ... page to learn more.We are looking for a Senior Director of Product Policy to lead a global team...for our Enforcement Operations, Product, Legal, Public Policy, Corporate Affairs , Communications and Sales teams, among others, and collaborate… more
- Gilead Sciences, Inc. (Foster City, CA)
- Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsJob DescriptionAt Gilead, we're creating a healthier world ... Join Gilead and help create possible, together.Job DescriptionThe Associate Director , Analytical Regulatory Science, collaborates with product development,… more
- Triton Medical Robotics (Burlingame, CA)
- …endoscopy. We have a fantastic team, technology, and investors. Title: Vice President of Quality Assurance & Regulatory Affairs POSITION SUMMARY: The company ... team and responsible for determining and achieving the company's quality and regulatory goals. In this role,...regulatory experience. Minimum 10 years of experience in Director and VP roles. Experience with bringing a product… more
- Adverum Biotechnologies (Redwood City, CA)
- The Director /Sr Regulatory Affairs will...Chain, and Quality ; and assist in ensuring regulatory compliance. The Director /Sr will be responsible ... development, regulatory , and registration strategies. What you'll do:Manage the Regulatory Affairs (CMC) Strategy for Regulatory AffairsStrengthen… more
- Guardant Health (Palo Alto, CA)
- Senior Medical Affairs Director , Molecular Tumor BoardsFull-timeGuardant Health is a leading precision oncology company focused on helping conquer cancer ... the needs of individuals eligible for cancer screening.Job DescriptionThe Senior Medical Affairs Director , Molecular Tumor Boards is responsible for leading the… more
- Stanford Health Care (Palo Alto, CA)
- …a Stanford Health Care job.** **A Brief Overview** The Senior Director of Quality Management and Regulatory Affairs is responsible for the strategic ... review process, and care improvement committee responsibilities. Reporting to the Executive Director for Quality , Patient Safety & Infection Prevention, the… more
- Kelly Services (Alameda, CA)
- ** Regulatory Affairs Policy, Intel, & Compliance Director ** + Direct Hire + Location: Alameda, CA or King of Prussia, PA + The base pay range: $183,000 - ... in regulatory requirements. Oversees Regulatory Affairs procedural documents in the Quality Management...Regulatory Affairs procedural documents in the Quality Management System. Establishes processes and measures to monitor… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction ... 5-7 years' experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs , operations, or… more
- Stryker (San Jose, CA)
- …(https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Regulatory ... partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Director will develop and...Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development, ... approval of regulatory control strategies. + Evaluates and implements new regulatory and quality requirements for analytical control strategy in partnership… more
