Senior Regulatory Affairs Manager Jobs in Sunnyvale, CA | Glassdoor
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Senior Regulatory Affairs Manager Jobs in Sunnyvale, CA

79 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.…
  • 5.0
    Dermira Inc. – Menlo Park, CA
    $86k-$174k(Glassdoor est.)
    NEW
    company. Lead, manage, and mentor regulatoryaffairs staff (clinical and CMC) and oversee interactions with regulatory operations… project teams and senior management as needed to provide guidance on regulatory issues. Manageregulatory relationships with…
  • 3.5
    Medtronic – Sunnyvale, CA
    $94k-$122k(Glassdoor est.)
    12 days ago 12d
    changes to existing products for impact on global regulatoryaffairs submissions. Manage commercial distribution of products by maintaining… RegulatoryAffairs experience is required. International RegulatoryAffairs experience is required. Non-technical degree with equivalent…
  • 2.0
    Pharmacyclics – Sunnyvale, CA
    $113k-$159k(Glassdoor est.)
    5 days ago 5d
    Biometrics, RegulatoryAffairs, etc.), to ensure effective delivery of the assigned project milestones Organizes and manages internal… conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions. Key…
  • 2.8
    Excelitas Technologies – Fremont, CA
    $125k-$180k(Glassdoor est.)
    16 days ago 16d
    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…
  • 3.2
    Gilead Sciences – Foster City, CA
    $94k-$128k(Glassdoor est.)
    HOT
    : Represent RegulatoryAffairs on internal and external cross-functional teams, providing regulatoryaffairs support and strategy… local process improvements which have an impact on the RegulatoryAffairs function and/or other departments. As necessary, liaise…
  • 3.2
    Gilead Sciences – Foster City, CA
    $124k-$168k(Glassdoor est.)
    NEW
    to project teams and senior management in a timely manner. The Manager will assist seniorRegulatoryAffairs personnel in local… from a seniorRegulatoryAffairs professional. The position will be recognized as a knowledgeable resource for regulatory advice…
  • 3.5
    Abbott – Santa Clara, CA
    $68k-$122k(Glassdoor est.)
    NEW
    contributor, the function of a SeniorRegulatoryAffairs Specialist is to provide support for the regulatory department to ensure efficient… experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations…
  • 4.0
    Stryker – Fremont, CA
    $86k-$122k(Glassdoor est.)
    11 days ago 11d
    Requisition ID 24184BR Job Title SeniorRegulatoryAffairs Specialist Group MedSurg and Neurotech Division Neurovascular… result, the Regulatory team is large and covers a broad swath of geographies and products. The NV RegulatoryAffairs organization…
  • 4.0
    Stryker – Fremont, CA
    $101k-$139k(Glassdoor est.)
    5 days ago 5d
    result, the Regulatory team is large and covers a broad swath of geographies and products. The NV RegulatoryAffairs organization… 400 submissions per year across the globe. The NV RegulatoryAffairs organization is leading the charge for stroke clinical…
  • 3.2
    Gilead Sciences – Foster City, CA
    $104k-$154k(Glassdoor est.)
    24 days ago 24d
    required. Work is performed under limited direction of a seniorRegulatoryAffairs professional. #LI-TM1 For jobs in the United… preparation of regulatory submissions -- which requires interaction with departments outside of RegulatoryAffairs -- for investigational…
  • 3.2
    Gilead Sciences – Foster City, CA
    $154k-$204k(Glassdoor est.)
    16 days ago 16d
    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…
  • 3.5
    Abbott – Pleasanton, CA
    $94k-$143k(Glassdoor est.)
    NEW
    contributor, the function of a RegulatoryAffairs Project Manager is to combine knowledge of scientific, regulatory and business issues to… is recognized as a discipline expert and resource in regulatoryaffairs. Qualifications Bachelor's degree (or equivalent…
  • 3.5
    Sutter Health System – Burlingame, CA
    $110k-$149k(Glassdoor est.)
    4 days ago 4d
    Description The Senior Project Manager provides strategic and operational support to Mills Peninsula RegulatoryAffairs Department… designed to improve regulatory compliance and continued preparedness for on site visits by all regulatory agencies. The incumbent…
  • 3.0
    Absolute Opportunities – Santa Clara, CA
    $89k-$142k(Glassdoor est.)
    15 days ago 15d
    SeniorRegulatoryAffairs Specialist - RT Santa Clara, California 95052 SeniorRegulatoryAffairs Specialist - RT IDEAL… , solid project / organizational skills. As a SeniorRegulatoryAffairs Specialist, your job responsibilities will include…
  • 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…
  • 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… DUTIES AND RESPONSIBILITIES: Manage daily operational activities for preparation of regulatory submissions (project management…
  • 3.6
    Abbott Laboratories – Santa Clara, CA
    $84k-$146k(Glassdoor est.)
    30+ days ago 30d+
    contributor, the function of a SeniorRegulatoryAffairs Specialist is to provide support for the regulatory department to ensure efficient… experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations…
  • 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… As a key member of the Quality Assurance team, the Manager/SeniorManager, GMP Quality Operations is responsible for building…
  • 4.0
    Stryker Corporation – Fremont, CA
    $101k-$139k(Glassdoor est.)
    16 days ago 16d
    result, the Regulatory team is large and covers a broad swath of geographies and products. The NV RegulatoryAffairs organization… advance your Regulatory career while engaging in our mission to fight stroke. The Stryker NV RegulatoryAffairs Team is determined…
  • 3.2
    Gilead Sciences – Foster City, CA
    6 days ago 6d
    minimal direction from a seniorregulatoryaffairs professional Must have in-depth knowledge of regulatory requirements, including… CMC functional groups as well as RegulatoryAffairs to plan and produce high quality regulatory submissions while meeting aggressive…
  • 3.2
    Gilead Sciences – Foster City, CA
    $164k-$258k(Glassdoor est.)
    5 days ago 5d
    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…
  • 4.2
    Intuit – Mountain View, CA
    $107k-$169k(Glassdoor est.)
    NEW
    collaborate and manage relationships with high-level internal and external stakeholders, and with regulatory and external independent… succinctly convey information to senior business and Compliance management. Exceptional ability to manage or support multiple programs…
  • 3.2
    Cepheid – Sunnyvale, CA
    $149k-$195k(Glassdoor est.)
    5 days ago 5d
    Operations, Operations Engineering, Program Management, and RegulatoryAffairs & Quality Systems. Duties and Responsibilities… business development, engineering, manufacturing, quality, and regulatory functions. Broad extensive knowledge of methods, processes…
  • 3.8
    Planet Pharma – Palo Alto, CA
    $89k-$128k(Glassdoor est.)
    16 days ago 16d
    BH36674 Category: RegulatoryAffairs Industry: Biotechnology The SeniorManager, Regulatory Strategy will be responsible… to regulations and applicable guidelines for all regulatory submissions Manage timelines to ensure approvals are timely and development…
  • 3.2
    Gilead Sciences – Foster City, CA
    $135k-$188k(Glassdoor est.)
    28 days ago 28d
    medical affairs strategy, as well as the market access strategy in coordination with the Market Access, RegulatoryAffairs and HEOR… Provides strategic direction and vision, represents the Medical Affairs function on Project Teams, and works as a team with the Business…
  • 4.0
    Stryker – San Jose, CA
    $67k-$106k(Glassdoor est.)
    13 days ago 13d
    Bachelor's degree; 1 year of experience with Master's degree. RegulatoryAffairs Certification preferred. Must be able to analyze and… and assess them for regulatory reporting Submit initial and follow-up reports to device related regulatory agencies as appropriate…
  • 5.0
    Dermira – Menlo Park, CA
    $138k-$171k(Glassdoor est.)
    8 days ago 8d
    SeniorManager/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…
  • 3.1
    Natera – San Carlos, CA
    $200k-$315k(Glassdoor est.)
    HOT
    Provide medical input into regulatory submissions Build and manage a top-class Medical Affairs department to achieve team… POSITION SUMMARY The Senior Medical Director, Oncology will be the head of Medical Affairs for Nateras burgeoning oncology…
  • 3.2
    Gilead Sciences – Foster City, CA
    $90k-$123k(Glassdoor est.)
    10 days ago 10d
    Under the direction of a seniorRegulatory Project Manager the Associate Manager in Regulatory Project Management will develop… communication among various RegulatoryAffairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising…
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