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Senior Director Regulatory Affairs Jobs in Fremont, CA

144 Jobs

  • 3.5
    Cytokinetics – South San Francisco, CA
    $110k-$234k(Glassdoor est.)
    23 days ago 23d
    Reporting to the Senior Vice President of Regulatory and Compliance, the Director of RegulatoryAffairs will be responsible… responsible for leading activities of RegulatoryAffairs with emphasis on global regulatory strategy and the preparation, review and submission…
  • 3.1
    Intarcia Therapeutics, Inc. – Hayward, CA
    $122k-$287k(Glassdoor est.)
    HOT
    key member of our diverse regulatoryaffairs team, the Director/SeniorDirector, RegulatoryAffairs will be responsible for developing… including IND, CTA, NDA and MAA. The Director/SeniorDirectorRegulatoryAffairs will be responsible for managing interactions with…
  • 2.8
    Excelitas Technologies – Fremont, CA
    $125k-$180k(Glassdoor est.)
    14 days ago 14d
    Director of Global RegulatoryAffairs and Compliance. RESPONSIBILITIES: Provide guidance and support sites with the implementation… Device regulatory bodies. This position will be located at the Fremont site and reports directly to Corporate Senior Director…
  • 3.5
    Cytokinetics – South San Francisco, CA
    $110k-$234k(Glassdoor est.)
    24 days ago 24d
    Reporting into the Senior Vice President of Regulatory and Compliance, the Director/SeniorDirector, RegulatoryAffairs will be responsible… responsible for leading activities of RegulatoryAffairs with an emphasis on global regulatory strategy and the preparation, review…
  • 5.0
    Dermira – Menlo Park, CA
    $86k-$174k(Glassdoor est.)
    6 days ago 6d
    Executive Director, RegulatoryAffairs POSITION PURPOSE: The Executive Director, RegulatoryAffairs is responsible for… , manage, and mentor regulatoryaffairs staff (clinical and CMC) and oversee interactions with regulatory operations staff to achieve…
  • 4.4
    Ascent Services Group – Pleasanton, CA
    NEW
    SeniorDirector Global RegulatoryAffairs CMC East San Francisco Bay Area Permanent Responsibilities: Work closely… of CMC regulatoryaffairs experience is preferable, or BS/MS in life sciences with 10+ years of CMC regulatoryaffairs experience…
  • 2.6
    Astex Pharmaceuticals – Pleasanton, CA
    $167k-$224k(Glassdoor est.)
    21 days ago 21d
    The SeniorDirector, Global RegulatoryAffairs - CMC will support oncology development programs, provide CMC regulatory expertise… of CMC regulatoryaffairs experience is preferable, or BS/MS in life sciences with 10+ years of CMC regulatoryaffairs experience…
  • 3.2
    Gilead Sciences – Foster City, CA
    $154k-$204k(Glassdoor est.)
    14 days ago 14d
    departments outside of RegulatoryAffairs. Responsible for submitting or ensuring submission of all regulatory documents required… trade groups and regulatoryaffairs professional societies. Maintains knowledge of highly complex regulatory requirements up to…
  • 4.4
    Ascent Services Group – Brisbane, CA
    7 days ago 7d
    Associate Director/Senior Manager RegulatoryAffairs San Francisco Bay Area or Seattle, WA Permanent Responsibilities… their outcomes Representing the regulatoryaffairs function in project teams to provide regulatory support and advice Interacting…
  • 3.1
    Intarcia Therapeutics, Inc. – Hayward, CA
    $163k-$219k(Glassdoor est.)
    NEW
    As a key member of our RegulatoryAffairs department, the Associate Director/Director, RegulatoryAffairs (Device) will be responsible… IDEs, 510(k)s. and/or PMAs required. At least 3 years of regulatoryaffairs with experience associated with global submissions.…
  • 3.5
    Abbott – Alameda, CA
    $168k-$226k(Glassdoor est.)
    28 days ago 28d
    Summary The function of Director, RegulatoryAffairs is to combine knowledge of scientific, regulatory and business issues to enable… and procedures for regulatoryaffairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles…
  • 3.2
    Actelion Group – South San Francisco, CA
    $115k-$189k(Glassdoor est.)
    9 days ago 9d
    RegulatoryAffairsDirector - (17000059) About the Company Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company… Company of Johnson & Johnson, is recruiting for RegulatoryAffairsDirector. As part of the Janssen Pharmaceutical Companies of…
  • 3.1
    Intarcia Therapeutics, Inc. – Hayward, CA
    $171k-$233k(Glassdoor est.)
    8 days ago 8d
    Opportunity As a key member of our RegulatoryAffairs department, the Director, RegulatoryAffairs (Early Development) will be responsible… Responsibilities: Represent RegulatoryAffairs during development projects to assure early consideration of regulatory and clinical requirements…
  • 3.2
    Gilead Sciences – Foster City, CA
    $164k-$258k(Glassdoor est.)
    4 days ago 4d
    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…
  • 2.8
    FivePrime Therapeutics – South San Francisco, CA
    $83k-$115k(Glassdoor est.)
    NEW
    Senior Medical Writer, RegulatoryAffairs Location: South San Francisco, CA Position type: Full time Five Prime Therapeutics… quality checking and reporting in compliance with GCP, SOPs and regulatory requirements. Review study-specific CDM documentation such…
  • 3.0
    Absolute Opportunities – Santa Clara, CA
    $89k-$142k(Glassdoor est.)
    14 days ago 14d
    SeniorRegulatoryAffairs Specialist - RT Santa Clara, California 95052 SeniorRegulatoryAffairs Specialist - RT IDEAL… , solid project / organizational skills. As a SeniorRegulatoryAffairs Specialist, your job responsibilities will include…
  • 3.2
    Gilead Sciences – Foster City, CA
    $124k-$168k(Glassdoor est.)
    28 days ago 28d
    from a seniorRegulatoryAffairs professional. The position will be recognized as a knowledgeable resource for regulatory advice… priorities. The Manager will report to an Associate Director in RegulatoryAffairs, Advertising and Promotion, and will review promotional…
  • 2.5
    Depomed, Inc. – Newark, CA
    $240k-$321k(Glassdoor est.)
    6 days ago 6d
    The Sr. Director of State Government Affairs will lead and execute the work of Depomed’s state government affairs activities… and policy objectives in coordination with VP of Government Affairs to ensure alignment with corporate goals and tracking progress…
  • 5.0
    Dermira Inc. – Menlo Park, CA
    $138k-$171k(Glassdoor est.)
    NEW
    diligence rooms for all Dermira projects. Collaborate with RegulatoryAffairs and contributing functional areas to create submission… Responsible for the daily operational activities for regulatory submissions and archives in accordance with agency requirements…
  • 3.1
    Rigel Pharmaceuticals – South San Francisco, CA
    $137k-$185k(Glassdoor est.)
    15 days ago 15d
    Vice President of RegulatoryAffairs, the successful candidate will provide expertise in translating regulatory requirements into… Authorities and manage the activities of other regulatoryaffairs staff or contract regulatory support in the performance of the duties…
  • 3.1
    Intarcia Therapeutics, Inc. – Hayward, CA
    $72k-$143k(Glassdoor est.)
    NEW
    assurance professionals Partner with Product Development, RegulatoryAffairs, Clinical Research, Facilities and Manufacturing to meet… diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities…
  • 3.1
    Intarcia Therapeutics, Inc. – Hayward, CA
    $103k-$226k(Glassdoor est.)
    13 days ago 13d
    compliance goals. Partner with Product Development, RegulatoryAffairs, Clinical Research, external vendors and partners to support… diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities…
  • 5.0
    Dermira – Menlo Park, CA
    $138k-$171k(Glassdoor est.)
    6 days ago 6d
    Senior Manager/Associate Director, Regulatory Operations JOB SUMMARY: Responsible for the daily operational activities… diligence rooms for all Dermira projects. Collaborate with RegulatoryAffairs and contributing functional areas to create submission…
  • 4.5
    Advanced Clinical – Fremont, CA
    HOT
    extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology Organized. You’re an…
  • 3.0
    AcelRx Pharmaceuticals, Inc – Redwood City, CA
    $90k-$217k(Glassdoor est.)
    11 days ago 11d
    REDWOOD CITY, CA - MUST BE ON-SITE The Director/SeniorDirector 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.…
  • 3.2
    Actelion Group – South San Francisco, CA
    $206k-$325k(Glassdoor est.)
    6 days ago 6d
    SeniorDirector Medical Affairs - (1700008A) About the Company Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company… Company of Johnson & Johnson, is recruiting for SeniorDirector Medical Affairs. As part of the Janssen Pharmaceutical Companies…
  • 3.4
    St. Jude Medical – Alameda, CA
    $201k-$273k(Glassdoor est.)
    30+ days ago 30d+
    and procedures for regulatoryaffairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles… (such as RAC from the RegulatoryAffairs Professionals Society.) 7-10 years of experience in regulatory preferred but may consider…
  • 3.2
    Gilead Sciences – Foster City, CA
    $164k-$258k(Glassdoor est.)
    17 days ago 17d
    The SeniorDirector, Global Medical Affairs, HEM-ONC will report into the Senior Vice President of Medical Affairs. Below outlines… and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough…
  • 5.0
    Dermira – Menlo Park, CA
    6 days ago 6d
    SeniorDirector, Healthcare Attorney Summary: Dermira is seeking an experienced Healthcare Attorney to be part of a… integrity agreements Provide legal support to the Medical Affairs and Commercial Departments related to HCP interactions and…
  • 3.2
    Gilead Sciences – Foster City, CA
    $117k-$185k(Glassdoor est.)
    22 days ago 22d
    Reporting to the SeniorDirector of HCV Medical Affairs, this role is a leadership position within the Medical Affairs organization… and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough…
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