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Regulatory Affairs Manager Jobs in Sunnyvale, CA

175 Jobs

  • 3.5
    Abbott – Pleasanton, CA
    $110k-$151k(Glassdoor est.)
    11 days ago 11d
    contributor, the function of a RegulatoryAffairs Project Manager is to combine knowledge of scientific, regulatory and business issues to… such as RAC from the RegulatoryAffairs Professionals Society). 5-8 years of experience in regulatoryaffairs preferred, but may…
  • 4.0
    Johnson & Johnson – Milpitas, CA
    $180k-$241k(Glassdoor est.)
    21 days ago 21d
    resource in regulatoryaffairs. Comments on changing regulations and guidance. Providing executive management with regulatory metrics… 10-15 years of experience in regulatory preferred. RAC certification from the RegulatoryAffairs Professionals Society a plus…
  • 4.8
    23andMe, Inc. – Mountain View, CA
    $80k-$114k(Glassdoor est.)
    HOT
    continuous improvements for RegulatoryAffairs and in support of the quality system Manageregulatory documentation (e.g., technical… . What youll do The RegulatoryAffairs Specialist is an integral member of the RegulatoryAffairs team. In this role, you…
  • 3.4
    Relypsa Inc. – Redwood City, CA
    $87k-$126k(Glassdoor est.)
    4 days ago 4d
    Summary: The Manager, RegulatoryAffairs will have broad Regulatory responsibilities and serve as the regulatory lead for designated… as Relypsa SOPs, where appropriate Independently manage routine regulatory submissions (e.g., Annual Reports, DSURs, Investigator…
  • 4.8
    23andMe, Inc. – Mountain View, CA
    $98k-$137k(Glassdoor est.)
    NEW
    As a key member of RegulatoryAffairs, this role will focus primarily on Post-Market Advertising, Labeling and Promotion. You… You will partner with internal stakeholders, and provide regulatory expertise and guidance needed for compliance of promotional material…
  • 3.1
    Gilead Sciences – Foster City, CA
    $96k-$203k(Glassdoor est.)
    6 days ago 6d
    access strategy in coordination with the Market Access, Regulatoryaffairs and HEOR teams. Provides strategic direction and vision… opportunity within our Medical Affairs team in the US for an Associate Director/Director, Medical Affairs within HIV. This role will…
  • 3.5
    Abbott – Santa Clara, CA
    $69k-$98k(Glassdoor est.)
    HOT
    contributor, the function of a RegulatoryAffairs Specialist is to provide support for the regulatory department to ensure efficient… preferred. Certification is a plus (such as RAC from the RegulatoryAffairs Professionals Society.) 2-3 years’ experience in a regulated…
  • 3.1
    Gilead Sciences – Foster City, CA
    $168k-$263k(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…
  • 3.5
    Abbott – Santa Clara, CA
    $73k-$129k(Glassdoor est.)
    24 days ago 24d
    contributor, the function of a Senior RegulatoryAffairs 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…
  • 3.8
    Orchard Therapeutics Limited – Foster City, CA
    $147k-$199k(Glassdoor est.)
    NEW
    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…
  • 4.4
    Dermira Inc. – Menlo Park, CA
    $87k-$174k(Glassdoor est.)
    22 days ago 22d
    company. Lead, manage, and mentor regulatoryaffairs staff (clinical and CMC) and oversee interactions with regulatory operations… POSITION PURPOSE: The Executive Director, RegulatoryAffairs is responsible for regulatory oversight for Dermiras biologic development…
  • 3.3
    Becton Dickinson and Company – San Jose, CA
    $100k-$135k(Glassdoor est.)
    10 days ago 10d
    Description The Sr. RegulatoryAffairs Specialist will be responsible for the preparation and approval of regulatory submissions required… are aligned with region/country need; BDB integrated RegulatoryAffairs Operating Plan (iRAOP) and Annual Strategic Review (ASR…
  • 3.6
    Spectraforce Technologies Inc – San Jose, CA
    26 days ago 26d
    Position- RegulatoryAffairs Specialist Location- San Jose, CA 95131 Duration- 11+ months Job Responsibilities… track, and prepare report from eGPS system. Brings RegulatoryAffairs questions/issues to the attention of RA management…
  • 2.7
    PaxVax – Redwood City, CA
    $84k-$122k(Glassdoor est.)
    26 days ago 26d
    PaxVax is seeking a highly motivated Manager, Global RegulatoryAffairs, who will be the Regulatory lead for one or more development… programs. The Manager, Global RegulatoryAffairs, will be responsible for leading the overall global regulatory strategy and plans…
  • 2.0
    Optra Health – Sunnyvale, CA
    $101k-$138k(Glassdoor est.)
    18 days ago 18d
    development team for regulatoryaffairs. Actively contributes to the development and implementation of regulatory strategy for assigned… Prepare, coordinate, manageregulatory submissions accordance with applicable regulations. Translate regulatory requirements into…
  • Eiger BioPharmaceuticals – Palo Alto, CA
    $162k-$194k(Glassdoor est.)
    30 days ago 30d+
    The Vice President of RegulatoryAffairs will manage and, as needed, build a premier regulatory group that provides strategic… President, RegulatoryAffairs will have a strong understanding of the US and global pharmaceutical drug development and regulatory environment…
  • 3.9
    Ardelyx, Inc. – Fremont, CA
    $69k-$100k(Glassdoor est.)
    NEW
    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…
  • 3.0
    Cepheid – Sunnyvale, CA
    $228k-$359k(Glassdoor est.)
    5 days ago 5d
    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…
  • 3.5
    Allergan – Pleasanton, CA
    $172k-$239k(Glassdoor est.)
    19 days ago 19d
    The RegulatoryAffairs Senior Manager will be a member of the Zeltiq, an Allergan Affiliate, regulatoryaffairs team located… BS or BA degree plus seven years’ experience in regulatoryaffairs, and at least five years in medical devices. *…
  • 3.4
    Relypsa Inc. – Redwood City, CA
    $136k-$182k(Glassdoor est.)
    24 days ago 24d
    The Associate Director, RegulatoryAffairs will be responsible for performing or managing key regulatory activities for the department… Participate on RegulatoryAffairs sub teams for activities related to the development of labeling for regulatory submissions.…
  • 2.0
    Pharmacyclics – Sunnyvale, CA
    19 days ago 19d
    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…
  • 2.9
    Apex Life Sciences – San Jose, CA
    $56k-$84k(Glassdoor est.)
    10 days ago 10d
    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…
  • East Bay Community Energy – Hayward, CA
    11 days ago 11d
    State Legislature. The Director of Regulatory and Legislative Affairs evaluates proposed regulatory policies to assess the impact on… Director of Regulatory and Legislative Affairs represents EBCE in administrative proceedings before applicable regulatory agencies…
  • 3.1
    Gilead Sciences – Foster City, CA
    17 days ago 17d
    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…
  • 3.7
    Shockwave Medical – Fremont, CA
    EASY APPLY
    $89k-$139k(Glassdoor est.)
    HOT
    (SWMI) Clinical Affairs is looking for an enthusiastic, motivated candidate to be a Clinical Research Manager in our dynamic environment… data listing, and report table levels Represent Clinical Affairs at the Project Team level for individual studies, as appropriate…
  • 3.1
    Mizuho OSI – Union City, CA
    $197k-$266k(Glassdoor est.)
    13 days ago 13d
    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…
  • 4.0
    Roche – Pleasanton, CA
    $112k-$160k(Glassdoor est.)
    14 days ago 14d
    Pleasanton Function RegulatoryAffairs Subfunction Diagnostics Business Area RegulatoryAffairs Schedule Full-time… education and work-related experience. 8+ years of regulatoryaffairs experience in the medical product industry. Travel…
  • 4.1
    Clinical Management Consultants – San Mateo, CA
    30+ days ago 30d+
    responses. The RegulatoryAffairsManager will educate staff on standards, monitor and report of preparedness. The RN Manager will ensure… California not-for-profit hospital is seeking a RegulatoryAffairs Nurse Manager to join their team. The facility is part of…
  • 2.9
    Natus Medical Incorporated – Pleasanton, CA
    $50k-$75k(Glassdoor est.)
    21 days ago 21d
    Position Title: RegulatoryAffairs Specialist Description: Prepare, submit, and coordinate medical device product registrations… equivalent experience Minimum of five years experience in regulatoryaffairs, including at least three years in the medical device…
  • 2.5
    Depomed – Newark, CA
    $176k-$279k(Glassdoor est.)
    18 days ago 18d
    experience in regulatoryaffairs in the pharmaceutical industry with at least 5 years in a leadership role with lead regulatory responsibilities… management oversight. •Possesses well-grounded knowledge of regulatoryaffairs principles, practices and systems, especially in the areas…
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