Senior Director Regulatory Affairs Jobs in Santa Clara, CA | Glassdoor
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Senior Director Regulatory Affairs Jobs in Santa Clara, CA

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  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $96k-$228k
    17 days ago 17d
    key member of our diverse regulatory affairs team, the Director/Senior Director, Regulatory Affairs will be responsible for developing… including IND, CTA, NDA and MAA. The Director/Senior Director Regulatory Affairs will be responsible for managing interactions with…
  • Absolute Opportunities – Santa Clara, CA
    Est. Salary $89k-$143k
    8 days ago 8d
    Senior Regulatory Affairs Specialist - RT Santa Clara, California 95052 Senior Regulatory Affairs Specialist -… , solid project / organizational skills. As a Senior Regulatory Affairs Specialist, your job responsibilities will include…
  • 3.9
    Guardant Health – Redwood City, CA
    Est. Salary $163k-$225k
    5 days ago 5d
    patients. As the Director, Regulatory Affairs you will support and provide input into the development of the regulatory strategy. The… Biological, Medical, Law, Chemical or Engineering field. Regulatory Affairs Certification (RAC) preferred Minimum of 8 years of…
  • 4.0
    Recruiter.com – Santa Clara, CA
    Est. Salary $70k-$106k
    30+ days ago 30d+
    skills, solid project / organizational skills. As a Senior Regulatory Affairs Specialist, your job responsibilities will include… design and development project teams as regulatory affairs representative. Ensure all regulatory requirements are met throughout the…
  • 3.3
    Becton Dickinson and Company – San Jose, CA
    Est. Salary $207k-$283k
    23 days ago 23d
    Description The Associate Director, Regulatory Affairs will lead, plan, coordinate, conduct and report on regulatory registration programs… compliant, current and efficient. The Associate Director Regulatory Affairs solves problems of high complexity and diverse scope…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $142k-$196k
    2 days ago 2d
    Opportunity The Director, Regulatory Affairs (Early Development) will be responsible for managing all regulatory aspects (Nonclinical… Responsibilities: Represent Regulatory Affairs during development projects to assure early consideration of regulatory and clinical requirements…
  • Versartis – Menlo Park, CA
    Est. Salary $118k-$303k
    30+ days ago 30d+
    Description Description The Director/Senior Director, Regulatory Affairs will support and lead regulatory activities and processes… related to regulatory affairs operations and strategy. Duties and Responsibilities - Essential Functions: · Provide regulatory leadership…
  • 3.1
    CareFusion – San Jose, CA
    Est. Salary $130k-$178k
    23 days ago 23d
    Description The Associate Director, Regulatory Affairs will lead, plan, coordinate, conduct and report on regulatory registration programs… compliant, current and efficient. The Associate Director Regulatory Affairs solves problems of high complexity and diverse scope…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $194k-$308k
    3 days ago 3d
    POSITION SUMMARY The Senior Medical Director, Oncology will be the head of Medical Affairs for Nateras burgeoning oncology… Provide medical input into regulatory submissions Build and manage a top-class Medical Affairs department to achieve team objectives…
  • 3.0
    Cepheid – Sunnyvale, CA
    27 days ago 27d
    analytical sections for regulatory submissions. * Interact with Regulatory Affairs and FDA or other regulatory and global (e.g. WHO… manually. JOB SUMMARY: Administer and supervise the Clinical Affairs department and external clinical review organization to monitor…
  • 2.6
    Astex Pharmaceuticals – Pleasanton, CA
    Est. Salary $152k-$209k
    16 days ago 16d
    The Senior Director, Global Regulatory Affairs - CMC will support oncology development programs, provide CMC regulatory expertise… of CMC regulatory affairs experience is preferable, or BS/MS in life sciences with 10+ years of CMC regulatory affairs experience…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $128k-$176k
    2 days ago 2d
    The Associate Director/Director, Regulatory Affairs (Device) will be responsible for managing all regulatory aspects for US and… IDEs, 510(k)s. and/or PMAs required. At least 3 years of regulatory affairs with experience associated with global submissions.…
  • 4.4
    Ascent Services Group – Pleasanton, CA
    24 days ago 24d
    Senior Director Global Regulatory Affairs CMC East San Francisco Bay Area Permanent Responsibilities: Work closely with… of CMC regulatory affairs experience is preferable, or BS/MS in life sciences with 10+ years of CMC regulatory affairs experience…
  • 3.5
    AstraZeneca – Redwood City, CA
    22 days ago 22d
    of smaller global function such as CMC, regulatory affairs directors, associate directors and managers, managing health authority… collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing views…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    24 days ago 24d
    departments (i.e., Clinical, Regulatory, Quality, Medical Affairs) and corporate partners. Support Senior Management of Pharmacovigilance… section in the IB. Contribution to safety analyses in Regulatory submissions (e.g. MAAs, NDAs). Signal Detection…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $86k-$124k
    10 days ago 10d
    representing Regulatory Affairs and foster positive and productive working relationships between project team members and regulatory agency… Prepare departmental guidelines for Regulatory Affairs and communicate new regulatory requirements across the company as appropriate…
  • Acelrx – Redwood City, CA
    Est. Salary $85k-$203k
    18 days ago 18d
    REDWOOD CITY, CA - MUST BE ON-SITE The Director/Senior Director of Scientific Affairs will be responsible for overall leadership… Pharmaceutical or Biotech Industry working in global Medical Affairs and/or clinical research and development or related fields.…
  • 3.4
    Genomic Health, Inc. – Redwood City, CA
    Est. Salary $259k-$411k
    2 days ago 2d
    The Senior Director will be responsible for the U.S. strategic management and direction of medical affairs activities supporting… Medical Affairs team consisting of Medical Director(s) and Medical Science Liaisons in the US. Core Medical Affairs responsibilities…
  • 3.5
    AstraZeneca – Redwood City, CA
    15 days ago 15d
    of smaller global function such as CMC, regulatory affairs directors, associate directors and managers, managing health authority… collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing views…
  • 3.8
    Jazz Pharmaceuticals – Palo Alto, CA
    Est. Salary $147k-$202k
    19 days ago 19d
    The Associate Director Regulatory Affairs Labeling will be responsible for regulatory support (both technical and operational… effectiveness of the label review process Work closely with Regulatory Affairs colleagues and Supply chain colleagues Provide project…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $169k-$266k
    26 days ago 26d
    and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough… Gilead Medical Affairs Plan (GMAP) for Inflammation • Write Plan of Action (PoA) for Inflammation Medical Affairs organization…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $53k-$134k
    4 days ago 4d
    submissions. Partners with Regulatory Affairs and QA to address responses to regulatory requests. Drives regulatory strategy and submissions… authoring, reviews and revisions of regulatory submissions as needed, in alignment with Regulatory Affairs CMC and QA on content of submissions…
  • AstraZeneca Pharmaceuticals LP – Redwood City, CA
    15 days ago 15d
    of smaller global function such as CMC, regulatory affairs directors, associate directors and managers, managing health authority… collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing views…
  • 4.2
    ZS Pharma – San Mateo, CA
    Est. Salary $118k-$220k
    1 days ago 21hr
    SUMMARY: The Senior Manager/Associate Director, Marketing Operations provides operational and project management across… program development to key stakeholders in Commercial, Medical Affairs, Market Access, and Insights Manages outside vendors…
  • 3.2
    Veritas – Mountain View, CA
    Est. Salary $142k-$299k
    18 days ago 18d
    Director/Senior Director – Intellectual Property Veritas Technologies is seeking a Director/Senior Director of IP to join our… dynamic, fast-paced and high-energy environment Global Legal Affairs team. The successful individual will have a demonstrated record…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $53k-$134k
    24 days ago 24d
    relationships with internal stakeholders within QC, QA, Regulatory Affairs, Development, Manufacturing and with external customers… diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities…
  • 4.2
    Stanford University – Stanford, CA
    Est. Salary $73k-$105k
    2 days ago 2d
    Associate Dean/Director in his/her absence. Represent the organization’s business operations and administrative affairs within the… Reporting to the Associate Dean/Director of Admission, the Senior Assistant Dean/Deputy Director of Admission will serve as one…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $82k-$180k
    26 days ago 26d
    medical affairs strategy, as well as the market access strategy in coordination with the Market Access, Regulatory Affairs and HEOR… Medical Affairs function on Project Teams, and works as a team with the Business Unit Director and Market Access Director. Regular…
  • 3.9
    Stanford School of Medicine – Stanford, CA
    5 days ago 5d
    . Working with the Director and key stakeholders (Associate Director of Development and the Academic Affairs Manager), this position… The Associate Director for Finance and Administration (Associate Director) serves as the chief business officer for the Hoover…
  • 3.9
    Guardant Health – Redwood City, CA
    8 days ago 8d
    Research Operations, Bioinformatics, Marketing, Medical Affairs, Regulatory and Finance. Collaboration is a key success factor.… attendance and other creative approaches. Youll work closely with senior leaders in drug development companies to build partnerships…
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