Senior Director Regulatory Affairs Jobs in Dublin, CA | Glassdoor
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Senior Director Regulatory Affairs Jobs in Dublin, CA

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  • 3.2
    Dynavax Technologies – Berkeley, CA
    Est. Salary $202k-$268k
    6 days ago 6d
    6+ years’ clinical regulatoryaffairs experience, with 2 years in a management role. The associate director level will have 8+… collaboratively implement the company’s regulatory strategies. The associate director level incumbent will provide strategic input…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $90k-$213k
    14 days ago 14d
    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…
  • Versartis – Menlo Park, CA
    Est. Salary $118k-$306k
    8 days ago 8d
    Description Description The Director/SeniorDirector, RegulatoryAffairs will support and lead regulatory activities and processes… initiatives related to regulatoryaffairs operations and strategy. Duties and Responsibilities - Essential Functions: · Provide…
  • 4.4
    Ascent Services Group – Pleasanton, CA
    21 days ago 21d
    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
    Est. Salary $160k-$212k
    13 days ago 13d
    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…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $116k-$156k
    28 days ago 28d
    The Associate Director/Director, RegulatoryAffairs (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 regulatoryaffairs with experience associated with global submissions.…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $157k-$210k
    NEW
    SUMMARY The Director, RegulatoryAffairs leads, plans, coordinates, conducts and reports on regulatory registration programs… strategies for a range of complex regulatoryaffairs programs with emphasis on requirements and submissions associated with IVD systems…
  • 3.0
    Absolute Opportunities – Santa Clara, CA
    Est. Salary $90k-$143k
    6 days ago 6d
    SeniorRegulatoryAffairs Specialist - RT Santa Clara, California 95052 SeniorRegulatoryAffairs Specialist -… , solid project / organizational skills. As a SeniorRegulatoryAffairs Specialist, your job responsibilities will include…
  • 3.0
    Mizuho OSI – Union City, CA
    Est. Salary $178k-$238k
    20 days ago 20d
    The Director of Quality Assurance and RegulatoryAffairs (QA/RA) leads the development efforts of Mizuho OSI?s position on medical… such as Quality Assurance Engineering, Document Control, RegulatoryAffairs, and Quality Operations. ? ESSENTIAL JOB FUNCTIONS…
  • 3.5
    Genomic Health – Redwood City, CA
    Est. Salary $263k-$414k
    NEW
    The SeniorDirector 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…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $128k-$174k
    28 days ago 28d
    Opportunity The Director, RegulatoryAffairs (Early Development) will be responsible for managing all regulatory aspects (Nonclinical… Responsibilities: Represent RegulatoryAffairs during development projects to assure early consideration of regulatory and clinical requirements…
  • 3.0
    Acelrx – Redwood City, CA
    Est. Salary $90k-$213k
    15 days ago 15d
    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
    Gilead Sciences – Foster City, CA
    Est. Salary $117k-$161k
    20 days ago 20d
    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…
  • 3.7
    Jazz Pharmaceuticals – Palo Alto, CA
    Est. Salary $143k-$292k
    NEW
    potential of Jazz candidates In collaboration with Medical Affairs, develops partnerships with academic labs for investigator… development and review of the pharmacology sections of relevant regulatory documents and filings. Develops strong working relationships…
  • 2.6
    Santen Inc – Emeryville, CA
    7 days ago 7d
    Provide status and analytical reports as requested to SeniorDirector of Scientific Communications and other internal stakeholders… adherence to global regulatory guidelines (e.g. FDA, EFIPA, PDMA, JPMA, PhRMA, etc.) Understanding of the regulatory and compliance…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $74k-$109k
    7 days ago 7d
    representing RegulatoryAffairs and foster positive and productive working relationships between project team members and regulatory agency… Prepare departmental guidelines for RegulatoryAffairs and communicate new regulatory requirements across the company as appropriate…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $164k-$258k
    24 days ago 24d
    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…
  • 3.7
    Jazz Pharmaceuticals – Palo Alto, CA
    Est. Salary $143k-$292k
    NEW
    project management, biostatics, data management, and regulatoryaffairs departments. Professionally network with bioanalytical… Organization, the SeniorDirector, Bioanalytical Sciences will be accountable for setting up the Bioanalytical strategy along with…
  • 2.6
    Santen Inc – Emeryville, CA
    Est. Salary $143k-$189k
    NEW
    Biostatistics, Drug Safety, and RegulatoryAffairs to fully understand development programs, regulatory and medical strategies, and… The Senior Medical Science Liaison (Senior MSL) role is a field-based position and reports to the Director, Medial Science Liaisons…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $164k-$258k
    9 days ago 9d
    Description 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…
  • 3.6
    AstraZeneca – Redwood City, CA
    12 days ago 12d
    of smaller global function such as CMC, regulatoryaffairsdirectors, associate directors and managers, managing health authority… collaboratively with the global/regional/local regulatoryaffairs staff at Acerta and AstraZeneca, to influence developing views…
  • 2.6
    Santen Inc – Emeryville, CA
    Est. Salary $107k-$201k
    NEW
    cross-functional leaders such as Commercial, Medical Affairs, Regulatory, Legal, Supply Chain, Information Technology, etc., the… readiness. Spearhead a Core-Team consisting of Medical Affairs, Regulatory, Legal, Pharmacovigilance, Quality Control, Quality Assurance…
  • 3.7
    Jazz Pharmaceuticals – Palo Alto, CA
    Est. Salary $149k-$199k
    20 days ago 20d
    The Associate DirectorRegulatoryAffairs Labeling will be responsible for regulatory support (both technical and operational)… effectiveness of the label review process Work closely with RegulatoryAffairs colleagues and Supply chain colleagues Provide project…
  • 1.7
    Revance – Newark, CA
    Est. Salary $89k-$136k
    4 days ago 4d
    travel. Works closely with the Clinical Science and Medical Affairs Leads as part of the Core Clinical Research Team. Experience… at par or ahead of Industry Standards, best practices and Regulatory requirements. Develops and implements clinical project plans…
  • AstraZeneca Pharmaceuticals LP – Redwood City, CA
    28 days ago 28d
    of smaller global function such as CMC, regulatoryaffairsdirectors, associate directors and managers, managing health authority… collaboratively with the global/regional/local regulatoryaffairs staff at Acerta and AstraZeneca, to influence developing views…
  • 2.6
    Santen Inc – Emeryville, CA
    Est. Salary $143k-$189k
    27 days ago 27d
    Biostatistics, Drug Safety, and RegulatoryAffairs to fully understand development programs, regulatory and medical strategies, and… The Senior Medical Science Liaison (Senior MSL) role is a field-based position and reports to the Director, Medial Science Liaisons…
  • Protagonist Therapeutics – Newark, CA
    NEW
    Medical Director/ Senior Medical Director Newark, California, United States Medical Director/ Senior Medical Director at Protagonist… closely with Program Management, Clinical Operations and RegulatoryAffairs, to align on current and projected clinical development…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $86k-$186k
    24 days ago 24d
    medical affairs strategy, as well as the market access strategy in coordination with the Market Access, RegulatoryAffairs and HEOR… Medical Affairs function on Project Teams, and works as a team with the Business Unit Director and Market Access Director. Regular…
  • 2.9
    Safeway Inc. – Pleasanton, CA
    NEW
    communications efforts. Communicate company positions on regulatoryaffairs issues to government agencies, interest groups, and elected… local government support to the Senior Vice President for Government Relations and divisional directors in achieving overall government…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $48k-$124k
    NEW
    submissions. Partners with RegulatoryAffairs 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 RegulatoryAffairs CMC and QA on content of submissions…
  • 3.9
    Stryker Corporation – Fremont, CA
    Est. Salary $121k-$167k
    NEW
    Under general supervision of the RegulatoryAffairs Department Manager or Director Prepares complex submissions to gain approvals… with in-country RegulatoryAffairs personnel to facilitate global clearances/approvals. Develops global regulatory strategies for…
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