- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director, CMC Regulatory Affairs for Biologics is ... with a specific product in Gilead's global portfolio of biological products in CMC Regulatory Affairs . This position will provide leadership at a product level… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company ... we pioneer progress in the biotechnology realm. **Position title:** Regulatory Affairs Senior Specialist, Global...position offers the opportunity to advise project teams on regulatory impacts, devise compliance strategies, and liaise… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Senior Regulatory Affairs Specialist** position is an on-site ... Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is...and approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability… more
- Stryker (San Jose, CA)
- …We are currently seeking a ** Senior Staff Regulatory ... improvement in functions. **What you will do** As the ** Senior Staff Regulatory Affairs Specialist**... regulatory impact, and completing actions to maintain regulatory compliance . + Assesses regulatory … more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Senior Manager** position is an onsite ... Abbott Vascular Division. The candidate will combine knowledge of scientific, regulatory , and business issues to enable products, including combination products,… 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 global … more
- Stanford Health Care (Palo Alto, CA)
- …**A Brief Overview** The Senior Director of Quality Management and Regulatory Affairs is responsible for the strategic planning, oversight and direction ... ensure that the organization is continually prepared for accreditation, federal and state regulatory surveys and compliance with all pertinent regulatory and… 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) ... science focused company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and Analytics this individual will be responsible for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Biliary Cholangitis (PBC). This role is based in Foster City, CA. Reporting to the Senior Director US Medical Affairs (USMA) Liver - PBC, this director role will ... projects. + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to lead...publications. + Must be fully aware and compliant with regulatory , compliance and legal requirements for clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and trainings + Partner cross functionally with Legal, Commercial, Clinical, Regulatory , Public and Government Affairs , to support cross-functional projects ... together. **Job Description** We are looking for a highly motivated Medical Affairs Associate Director who is passionate about HIV prevention and Pre-exposure… more
- Kelly Services (Alameda, CA)
- …guide audit planning, audit frequency, and tracking of findings to ensure regulatory compliance . + Lead inspection readiness activities, including mock ... Hire Shift: M-F 8a-5p Salary: 200K-250K + DOE The Senior Director will lead QA compliance across...primary QA liaison, managing communication between teams and ensuring compliance with global regulatory standards. The Director… more
- Microsoft Corporation (Mountain View, CA)
- …Microsoft's Cloud Operations + Innovation has an immediate opening in the role of Senior Corporate Counsel, Datacenter Regulatory Compliance . This is a ... Microsoft's license to operate + Contribute to horizontal regulatory compliance initiatives in partnership with, Government Affairs , commercial legal,… more
- Abbott (Alameda, CA)
- …submission and approval requirements. + Participate in risk benefit analysis for regulatory compliance . + Assess the acceptability of documentation for gap ... levels with our new sensing technology. **The Opportunity** This ** Senior International Regulatory Operations Specialist** will work...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + 2-3 years… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs - Systems and Operations at Gilead. **JOB DESCRIPTION** + ... more than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Head will play a leadership role in developing and implementing Global Regulatory Affairs infrastructure, compliance , process, and capability development. ... and identify key business drivers and work with the Senior Leadership team to prioritise these, before driving implementation...processes are in place for Global Regulatory Affairs to function efficiently and in compliance … more
- Lucile Packard Children's Hospital Stanford (Palo Alto, CA)
- …safety, patient experience, engagement and wellness, and financial strength. Regulatory Affairs : + Leads regulatory compliance with and preparation for ... throughout the greater Bay Area, and beyond. As the Senior Associate Dean for Maternal and Child Health, partners...Chief Compliance Officer to ensure conformity with regulatory requirements. Support for Medical Staff Affairs :… more
- AbbVie (South San Francisco, CA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory ... interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements.… more
- Danaher Corporation (Sunnyvale, CA)
- …market access teams, HEOR, government affairs , medical & scientific affairs , product management, marketing, commercial, regulatory and clinical affairs ... The Senior Manager, Market Access Strategy & Payer Value...care organizations. This position is part of the Government Affairs and Market Access Team and will be located… more
- BeiGene (San Mateo, CA)
- …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional… more
- Gilead Sciences, Inc. (Foster City, CA)
- …control strategy in partnership with organizations across Technical Development, Quality, Regulatory Affairs CMC, and Manufacturing. + Lead purification process ... to ensure compliance . Lead manufacturing atypical event investigations. + Support regulatory filings by guiding the draft, review, and approval of CMC sections;… more