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Director Clinical and Regulatory Affairs Jobs in Alameda, CA

170 Jobs

  • 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.)
    NEW
    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…
  • 3.5
    Cytokinetics – South San Francisco, CA
    $110k-$234k(Glassdoor est.)
    HOT
    of Regulatory and Compliance, the Director of RegulatoryAffairs will be responsible for leading activities of Regulatory Affairs… Supervises employees, consultants/contractors in RegulatoryAffairs Optimizes employee performance by developing employees…
  • 3.1
    Intarcia Therapeutics, Inc. – Hayward, CA
    $122k-$287k(Glassdoor est.)
    HOT
    key member of our diverse regulatoryaffairs team, the Director/Senior Director, RegulatoryAffairs will be responsible for developing… including IND, CTA, NDA and MAA. The Director/Senior DirectorRegulatoryAffairs will be responsible for managing interactions with…
  • 4.7
    Shockwave Medical – Fremont, CA
    EASY APPLY
    HOT
    conformance with applicable regulatory requirements to meet business objectives. The Director of ClinicalAffairs will establish processes… plaque. The Director of ClinicalAffairs will play a key leadership role for the Company’s ClinicalAffairs including study…
  • 3.5
    Singulex – Alameda, CA
    $160k-$223k(Glassdoor est.)
    30+ days ago 30d+
    degree preferred or a focused degree in RegulatoryAffairs. 10+ years related regulatory experience In-vitro diagnostic (reagents… leadership skills and experience in managing a department of RegulatoryAffairs professionals. Further, the candidate will have extensive…
  • 5.0
    Dermira – Menlo Park, CA
    $86k-$174k(Glassdoor est.)
    7 days ago 7d
    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…
  • 3.2
    Gilead Sciences – Foster City, CA
    $154k-$204k(Glassdoor est.)
    15 days ago 15d
    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…
  • 3.1
    BioMarin Pharmaceutical – San Rafael, CA
    $69k-$148k(Glassdoor est.)
    NEW
    Associate Director/Director will focus on clinical and nonclinical aspects of domestic and international regulatoryaffairs for a… to the Senior Director, RegulatoryAffairs for assigned product. Associate Director/Director, RegulatoryAffairs Define…
  • 3.8
    Orchard Therapeutics Limited – Foster City, CA
    $147k-$199k(Glassdoor est.)
    7 days ago 7d
    requests for information from regulatory authorities Train and mentor other regulatoryaffairs personnel As primary objective… year ago, it is in an exciting start-up phase where a RegulatoryAffairs professional can have a real impact on the work and foundations…
  • 2.9
    Relypsa Inc. – Redwood City, CA
    $136k-$182k(Glassdoor est.)
    NEW
    The Associate Director, RegulatoryAffairs will be responsible for performing or managing key regulatory activities for the… Participate on RegulatoryAffairs sub teams for activities related to the development of labeling for regulatory submissions.…
  • 3.4
    TOSOH GROUP AMERICA – San Francisco, CA
    EASY APPLY
    $197k-$264k(Glassdoor est.)
    NEW
    administrative direction of the president, the Director of RegulatoryAffairs and Quality Assurance is responsible for the successful… situations arise. REGULATORYAFFAIRS: Essential Duties and Responsibilities Oversee RegulatoryAffairs by directing and…
  • 3.2
    Prothena – South San Francisco, CA
    $57k-$132k(Glassdoor est.)
    4 days ago 4d
    work with the Director of RegulatoryAffairs and global regulatory team towards the development of global regulatory strategies… objectives, the Associate Director of RegulatoryAffairs will be responsible for developing regulatory strategies, planning, managing…
  • Bay Labs – San Francisco, CA
    $151k-$247k(Glassdoor est.)
    9 days ago 9d
    position offers a visionary, high-energy, and hands-on RegulatoryAffairs and Quality Assurance expert the opportunity to take a… requirements of our target markets. You will plan and lead regulatoryaffairs, including preparing submissions for clearances and registrations…
  • 5.0
    Intersect ENT, Inc. – Menlo Park, CA
    $88k-$125k(Glassdoor est.)
    4 days ago 4d
    Responsible for working closely with the Director, RegulatoryAffairs todevelop regulatory strategies for US and international submissions… labeling and promotional materials. Provide regulatory assistance and review in clinical operations activities, including review of…
  • 3.1
    Rigel Pharmaceuticals – South San Francisco, CA
    $137k-$185k(Glassdoor est.)
    16 days ago 16d
    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…
  • 4.4
    Ascent Services Group – San Rafael, CA
    14 days ago 14d
    Associate Director/Director, RegulatoryAffairs San Rafael, CA Permanent Responsibilities: Define the clinical and nonclinical… experience in RegulatoryAffairs or a related discipline in the pharmaceutical or biotechnology industry with a clinical and nonclinical…
  • VIR – San Francisco, CA
    $40k-$94k(Glassdoor est.)
    10 days ago 10d
    initially reporting to the COO, the Associate Director / Director, RegulatoryAffairs will be responsible for overseeing the global… of the regulatoryaffairs objectives. Specific responsibilities include: Oversees the development of regulatory strategies…
  • 4.4
    Ascent Services Group – Brisbane, CA
    8 days ago 8d
    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…
  • 3.5
    Cytokinetics – South San Francisco, CA
    $110k-$234k(Glassdoor est.)
    24 days ago 24d
    Senior Vice President of Regulatory and Compliance, the Director/Senior Director, RegulatoryAffairs will be responsible for leading… leading activities of RegulatoryAffairs with an emphasis on global regulatory strategy and the preparation, review and submission…
  • 4.4
    Ascent Services Group – Pleasanton, CA
    NEW
    Senior Director 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…
  • 3.0
    Avalanche Biotech – Menlo Park, CA
    $99k-$140k(Glassdoor est.)
    25 days ago 25d
    options. Director of RegulatoryAffairs is responsible leading the overall regulatory strategy for Adverum’s clinical development… minimum of 12 years of experience in RegulatoryAffairs. This Director will be the regulatory lead internally and externally with…
  • 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… Represent RegulatoryAffairs during development projects to assure early consideration of regulatory and clinical requirements…
  • 2.7
    PaxVax, Inc. – Redwood City, CA
    $139k-$188k(Glassdoor est.)
    7 days ago 7d
    PaxVax is seeking a highly motivated Director, Global RegulatoryAffairs, who will be the Regulatory lead for one or more development… development programs. The Director, Global RegulatoryAffairs, will provide leadership on the worldwide development of vaccine candidates…
  • 3.0
    Ultragenyx Pharmaceuticals – Brisbane, CA
    $171k-$230k(Glassdoor est.)
    30 days ago 30d+
    background with at least seven (7) years of experience in RegulatoryAffairs in the biotechnology or pharmaceutical industries Thorough… Create and maintain regulatory timelines and track deliverables to timelines to ensure that regulatory submission timelines are…
  • 4.4
    Ascent Services Group – Pleasanton, CA
    14 days ago 14d
    Associate Director/Director, Global RegulatoryAffairs Pleasanton, CA Permanent Responsibilities: Will support… years of regulatoryaffairs experience is preferable, or BS/MS in life sciences with 8+ years of regulatoryaffairs experience…
  • 3.0
    Ultragenyx Pharmaceutical – Brisbane, CA
    $200k-$291k(Glassdoor est.)
    4 days ago 4d
    Ultragenyx is seeking a highly motivated VP or Executive Director, RegulatoryAffairs CMC, who is a team builder and enjoys a fast paced… for leading the RegulatoryAffairs CMC group and developing, implementing, and advising on global CMC regulatory strategies for…
  • 3.8
    Orchard Therapeutics – Foster City, CA
    EASY APPLY
    $147k-$199k(Glassdoor est.)
    9 days ago 9d
    requests for information from regulatory authorities Train and mentor other regulatoryaffairs personnel As primary objective… year ago, it is in an exciting start-up phase where a RegulatoryAffairs professional can have a real impact on the work and foundations…
  • 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… reports to the Director of Clinical Data Management. Key responsibilities include: Provide oversight of clinical data management…
  • 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… years experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical…
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