Job Type
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Regulatory Affairs Manager Jobs in Sunnyvale, CA

193 Jobs

  • 3.2
    Gilead Sciences – Foster City, CA
    4 days ago 4d
    discipline and minimum 10 years of relevant experience in RegulatoryAffairs. An advanced degree is desirable. Must be a detail-oriented… preparing regulatory documents while meeting aggressive timelines. Ensures regulatory submissions are in line with regulatory requirements…
  • 3.9
    NeoTract – Pleasanton, CA
    7 days ago 7d
    treat even more patients. About the Position The Manager, Clinical Affairs is responsible for leadership and execution of clinical… As an integral member of the Clinical Affairs team, this position executes and manages all aspects of multi-center global clinical…
  • 3.0
    Cepheid – Sunnyvale, CA
    $228k-$359k(Glassdoor est.)
    25 days ago 25d
    cannot be managed by Technical Support personnel. Assist the Senior Vice President, Quality and RegulatoryAffairs and the Vice… responding to regulatory agencies as needed. Serve as internal consultant and participate with Vice President, Government Affairs, in responding…
  • 3.0
    Cepheid – Sunnyvale, CA
    $228k-$359k(Glassdoor est.)
    19 days ago 19d
    cannot be managed by Technical Support personnel. Assist the Senior Vice President, Quality and RegulatoryAffairs and the Vice… responding to regulatory agencies as needed. Serve as internal consultant and participate with Vice President, Government Affairs, in responding…
  • 3.4
    Danaher – Sunnyvale, CA
    $219k-$345k(Glassdoor est.)
    25 days ago 25d
    cannot be managed by Technical Support personnel. Assist the Senior Vice President, Quality and RegulatoryAffairs and the Vice… responding to regulatory agencies as needed. Serve as internal consultant and participate with Vice President, Government Affairs, in responding…
  • 3.9
    Boston Scientific – San Jose, CA
    6 days ago 6d
    This role will be responsible for RegulatoryAffairs support of submissions and on going regulatory compliance for product development… Provides technical guidance and regulatory training/mentoring to other RegulatoryAffairs employees and cross-functional teams…
  • 3.2
    Intarcia Therapeutics, Inc. – Hayward, CA
    $126k-$300k(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 Director RegulatoryAffairs will be responsible for managing interactions with health…
  • 4.1
    Ardelyx – Fremont, CA
    $56k-$91k(Glassdoor est.)
    28 days ago 28d
    role of regulatoryaffairs eCTD formatting and publication. This individual will ensure that documents comply with regulatory and… RegulatoryAffairs eCTD Publication Operations Specialist IV Ardelyx® is building an integrated biopharmaceutical company with…
  • 3.4
    Danaher – Sunnyvale, CA
    25 days ago 25d
    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…
  • 3.2
    Gilead Sciences – Foster City, CA
    $140k-$213k(Glassdoor est.)
    6 days ago 6d
    personnel in Global Medical Affairs, Clinical Research, Marketing, Market Access, HEOR, Regulatory, and Business Conduct Providing… opportunity within our US Medical Affairs team in the for a Senior Manager/ Associate Director, Medical Affairs within Inflammation. This…
  • 3.0
    Cepheid – Sunnyvale, CA
    25 days ago 25d
    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…
  • 2.9
    Astex Pharmaceuticals – Pleasanton, CA
    $57k-$132k(Glassdoor est.)
    5 days ago 5d
    years of regulatoryaffairs experience is preferable, or BS/MS in life sciences with 8+ years of regulatoryaffairs experience… Director/Director, Global RegulatoryAffairs will support oncology development programs, provide regulatory expertise and support…
  • 2.9
    Apex Life Sciences – San Jose, CA
    $58k-$85k(Glassdoor est.)
    30+ days ago 30d+
    Senior RegulatoryAffairs Analyst Ensures regulatory compliance by completing the appropriate filings and documentation pertaining… with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways…
  • 3.9
    Boston Scientific – Fremont, CA
    6 days ago 6d
    Responsible for RegulatoryAffairs support of the product development process, submissions and regulatory compliance. Your… discipline required. Advanced degree preferred. 3+ years RegulatoryAffairs medical industry experience required; specific medical…
  • 4.4
    Google – Sunnyvale, CA
    NEW
    in new and existing areas. Provide support to government affairs, community engagement and diverse local community groups, including… with applicable land use requirements. Assist with other regulatory and utility bodies in obtaining approvals on infrastructure…
  • 3.0
    Corcept Therapeutics Incorporated – Menlo Park, CA
    6 days ago 6d
    liaison between clinical, drug safety, regulatory, and commercial for all medical affairs related activities and issues Thought… Comprehensive understanding of Medical Affairs and the compliance issues concerning medical affairs functions Proven leadership and…
  • 2.6
    Adverum Biotechnologies – Menlo Park, CA
    5 days ago 5d
    Vice President or Director of RegulatoryAffairs. Serve as the business lead on Regulatory-IT projects for implementing or… Serve as Regulatory Project Lead for identified submission projects. Partner with project teams (RegulatoryAffairs and contributing…
  • 4.1
    Daimler – Sunnyvale, CA
    6 days ago 6d
    fuel cell and battery electric vehicles. The Testing and RegulatoryAffairs Division in Ann Arbor and the Advanced Vehicle Design…
  • 3.9
    Planet Pharma – Pleasanton, CA
    5 days ago 5d
    Clinical Trial Manager Industry: Medical Device About the Position The Senior Manager, Clinical Affairs is responsible… As an integral member of the Clinical Affairs team, this position executes and manages all aspects of multi-center global clinical…
  • 3.2
    Gilead Sciences – Foster City, CA
    $196k-$298k(Glassdoor est.)
    NEW
    and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough… Director, Global Medical Affairs, HEM-ONC will report into the Senior Vice President of Medical Affairs. Below outlines and lists…
  • 2.1
    Pharmacyclics – Sunnyvale, CA
    5 days ago 5d
    its SOP. The Manager works closely with cross-functional partners including Marketing, Market Access, Regulatory, Legal, Compliance… process • Manage Subpart-H-related promotional materials planning and submissions. • Partner with/Support Regulatory Affairs…
  • 5.0
    CMP.jobs – Sunnyvale, CA
    12 days ago 12d
    process Manage Subpart-H-related promotional materials planning and submissions. Partner with/Support RegulatoryAffairs in Office… its SOP. The Manager works closely with cross-functional partners including Marketing, Market Access, Regulatory, Legal, Compliance…
  • 2.2
    Leica Biosystems – Sunnyvale, CA
    $104k-$143k(Glassdoor est.)
    NEW
    The selected Senior RegulatoryAffairs Specialist will represent RA on project core teams and provide other department support… 13485 PREFERRED REQUIREMENTS (optional): 5 years RegulatoryAffairs experience RAC Certification (US) Device industry…
  • 3.6
    AstraZeneca – Redwood City, CA
    $92k-$132k(Glassdoor est.)
    NEW
    and Tremelimumab), moxetumomab and roxadustat. Global Medical Affairs leaders to be hired to support those molecules will report… sub-specialty in Hematology or Oncology preferred). Medical Affairs experience (4+ years) is required and clinical development…
  • 4.3
    Intuitive Surgical – Sunnyvale, CA
    $96k-$135k(Glassdoor est.)
    13 days ago 13d
    support of business goals through Clinical Affairs activities Assist Clinical AffairsManager/Director for building departmental process… Function of Position: This position reports to Manager, Clinical Affairs and requires a strong candidate looking to develop…
  • 4.2
    Ascent Services Group – Menlo Park, CA
    19 days ago 19d
    the Vice President or Director of RegulatoryAffairs. Serve as the business lead on Regulatory-IT projects for implementing or… Serve as Regulatory Project Lead for identified submission projects. Partner with project teams (RegulatoryAffairs and contributing…
  • 3.2
    Gilead Sciences – Foster City, CA
    $164k-$228k(Glassdoor est.)
    18 days ago 18d
    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…
  • 3.2
    Gilead Sciences – Foster City, CA
    $125k-$188k(Glassdoor est.)
    14 days ago 14d
    relevant experience with MA/MS degree within clinical R&D or regulatoryaffairs such as pharmaceuticals/biotechnology, including a minimum… variety of regulatory submissions across all therapeutic indications. Functions as the Quality Lead for complex regulatory deliverables…
  • 3.2
    Intarcia Therapeutics, Inc. – Hayward, CA
    $77k-$155k(Glassdoor est.)
    HOT
    Partner with other functions i.e., Product Development, RegulatoryAffairs, Clinical Research, Facilities and Manufacturing to meet… Duties and Responsibilities: Independently perform and/or manage lot release activities for raw materials, product intermediates…
  • 3.7
    Abbott Laboratories – Sunnyvale, CA
    $91k-$123k(Glassdoor est.)
    6 days ago 6d
    submission for regulatory approvals and acts independently to identify and resolve problems. Provides regulatory guidance to cross-functional… orders. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact…
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