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Regulatory and Scientific Affairs Manager Jobs in Sunnyvale, CA

90Jobs

  • 3.5
    Abbott – Sunnyvale, CA
    $123k-$180k(Glassdoor est.)
    7 days ago 7d
    direction of the RegulatoryAffairs Associate Director. Supports project teams to obtain worldwide regulatory approval or clearance… as a mentor for RegulatoryAffairs Coordinators, Associates, and Assistants. 2) Develop global regulatory strategies for new…
  • 2.0
    Pharmacyclics – Sunnyvale, CA
    $94k-$172k(Glassdoor est.)
    22 days ago 22d
    development or medical affairs very beneficial. Minimum of 3-5+ years of relevant RegulatoryAffairs, Advertising and Promotional… competing perspectives and provide clear regulatory guidance. · Applies regulatory and therapeutic area knowledge to Brand Team…
  • 2.0
    Pharmacyclics – Sunnyvale, CA
    $109k-$148k(Glassdoor est.)
    NEW
    Clinical Science, Safety Science, Biometrics, Regulatory, Quality, Commercial, Medical Affairs, or Clinical Operations is preferred.… includes: (1) developing an understanding of the scientific, clinical, regulatory, commercial, and strategic context of the meeting…
  • 3.1
    Gilead Sciences – Foster City, CA
    $122k-$165k(Glassdoor est.)
    NEW
    preparation of regulatory submissions -- which requires interaction with departments outside of RegulatoryAffairs -- for investigational… development of regulatoryaffairs CMC strategy for investigational and commercial drug products. Communicate complex regulatory affairs…
  • 3.1
    Gilead Sciences – Foster City, CA
    NEW
    and that sound scientific justification is employed in CMC regulatory strategy. Provides strategic regulatory advice as appropriate… discipline and minimum 10 years of relevant experience in RegulatoryAffairs. An advanced degree is desirable. Must be a detail-oriented…
  • 4.1
    millenniumsoft – San Jose, CA
    $63k-$98k(Glassdoor est.)
    4 days ago 4d
    Position : RegulatoryAffairs Specialist Location : San Jose, CA Duration : 12 Months Contract Start Time : 08:00 AM… track, and prepare report from eGPS system. Brings RegulatoryAffairs questions/issues to the attention of RA management.…
  • 4.9
    23andMe, Inc. – Mountain View, CA
    $98k-$137k(Glassdoor est.)
    14 days ago 14d
    As a key member of RegulatoryAffairs, this role will focus primarily on Post-Market Advertising, Labeling and Promotion. You… audiences such as healthcare providers, academics and the scientific community Ensure labeling changes are reviewed and if appropriate…
  • 3.9
    NeoTract – Pleasanton, CA
    NEW
    for on time delivery with the highest scientific value. Collaborate with medical affairs colleagues to develop CEC and DMC charters… more patients. About the Position The Senior Manager, Clinical Affairs is responsible for leadership and execution of clinical…
  • 3.5
    Abbott – Santa Clara, CA
    $73k-$129k(Glassdoor est.)
    7 days ago 7d
    experience in regulatory preferred but may consider quality assurance, research and development/support, scientificaffairs, operations… specific regulatory support Position Accountability / Scope: Individuals execute and manage technical and scientific regulatory…
  • 3.5
    Abbott – Santa Clara, CA
    $69k-$98k(Glassdoor est.)
    HOT
    nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientificaffairs, operations… contributor, the function of a RegulatoryAffairs Specialist is to provide support for the regulatory department to ensure efficient…
  • 4.2
    Ascent Services Group – Palo Alto, CA
    6 days ago 6d
    Senior ManagerRegulatoryAffairs Palo Alto, CA Permanent Responsibilities: Participate as an active member of… Masters or advanced degree in a scientific discipline, with 5+ years of increasingly responsible regulatory experience in the pharmaceutical…
  • 3.5
    Abbott – Santa Clara, CA
    NEW
    function of an Associate Director RegulatoryAffairs is to combine knowledge of scientific, regulatory and business issues to enable… Define regulatory strategy Follow scientific arguments, identify regulatoryscientific data needs and solve regulatory issues…
  • 2.9
    Apex Life Sciences – San Jose, CA
    $56k-$84k(Glassdoor est.)
    8 days ago 8d
    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…
  • 3.6
    Abbott Laboratories – Sunnyvale, CA
    $103k-$153k(Glassdoor est.)
    30+ days ago 30d+
    direction of the RegulatoryAffairs Associate Director. Supports project teams to obtain worldwide regulatory approval or clearance… as a mentor for RegulatoryAffairs Coordinators, Associates, and Assistants. 2) Develop global regulatory strategies for new…
  • 4.0
    Axelon Services Corporation – San Jose, CA
    $67k-$102k(Glassdoor est.)
    25 days ago 25d
    RegulatoryAffairs Specialist San Jose, CA 2+ Months Responsible for the preparation and documentation of regulatory… track, and prepare report from eGPS system. 8. Brings RegulatoryAffairs questions/issues to the attention of RA management. 9.…
  • 3.1
    Gilead Sciences – Foster City, CA
    $135k-$189k(Glassdoor est.)
    5 days ago 5d
    medical affairs strategy, as well as the market access strategy in coordination with the Market Access, RegulatoryAffairs and HEOR… experts including medical professionals, societies, and regulatory at scientific meetings. Develops and leads plans with national cooperative…
  • 3.1
    Optovue – Fremont, CA
    $105k-$151k(Glassdoor est.)
    6 days ago 6d
    November 17, 2017 The Manager, Regulatory and Quality Affairs overseas and manages all the regulatory activities. He/she is responsible… in a relevant technical or scientific field is required. Advanced degree and/or regulatoryaffairs certification (RAC) preferred…
  • Eiger BioPharmaceuticals – Palo Alto, CA
    $162k-$194k(Glassdoor est.)
    13 days ago 13d
    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…
  • 4.0
    Stryker – Fremont, CA
    $108k-$148k(Glassdoor est.)
    NEW
    International RegulatoryAffairsManager Group MedSurg and Neurotech Division Neurovascular Business Function Regulatory Affairs… and Regulatory matters and in effective business partnering with Marketing, R&D, and Clinical. Provide regulatoryaffairs training…
  • 3.1
    Gilead Sciences – Foster City, CA
    $94k-$129k(Glassdoor est.)
    22 days ago 22d
    4+ years of RegulatoryAffairs and/or related experience (preferably in GMP environment). Degree in a scientific field is preferred… of regulatoryaffairs CMC strategy for investigational and commercial drugs. Communicate submission status and regulatory affairs…
  • 3.0
    Cepheid – Sunnyvale, CA
    $117k-$175k(Glassdoor est.)
    NEW
    Operations, Operations Engineering, Program Management, and RegulatoryAffairs & Quality Systems. Duties and Responsibilities… Demonstrated ability to coach, mentor and develop technical and scientific talent within the company. Proven ability to function in…
  • 3.5
    Abbott – Santa Clara, CA
    $74k-$103k(Glassdoor est.)
    18 days ago 18d
    experience in regulatory preferred but may consider quality assurance, research and development/support, scientificaffairs, operations… relationships · Define regulatory strategy with supervision · Follow scientific arguments, identify regulatoryscientific data needs and…
  • 3.0
    Cepheid – Sunnyvale, CA
    $228k-$359k(Glassdoor est.)
    14 days ago 14d
    cannot be managed by Technical Support personnel. Assist the Senior Vice President, Quality and RegulatoryAffairs and the Vice… bulletins, etc. for both grammatical and scientific accuracy. Assist Clinical Affairs with laboratory aspects of clinical trials…
  • 3.6
    Abbott Laboratories – Santa Clara, CA
    $82k-$113k(Glassdoor est.)
    13 days ago 13d
    experience in regulatory preferred but may consider quality assurance, research and development/support, scientificaffairs, operations… relationships · Define regulatory strategy with supervision · Follow scientific arguments, identify regulatoryscientific data needs and…
  • 3.6
    Spectraforce Technologies Inc – San Jose, CA
    9 days ago 9d
    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…
  • 4.3
    Stanford University – Stanford, CA
    $86k-$128k(Glassdoor est.)
    NEW
    specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and… in a dynamic research setting. Strong knowledge of regulatoryaffairs, including FDA regulations, IRB review and approval process…
  • 3.1
    Gilead Sciences – Foster City, CA
    11 days ago 11d
    CMC functional groups as well as RegulatoryAffairs to plan and produce high quality regulatory submissions while meeting aggressive… minimal direction from a senior regulatoryaffairs professional Must have in-depth knowledge of regulatory requirements, including ICH…
  • 2.0
    Pharmacyclics – Sunnyvale, CA
    $106k-$150k(Glassdoor est.)
    17 days ago 17d
    development or medical affairs very beneficial. Minimum of 3-5+ years of relevant RegulatoryAffairs, Advertising and Promotional… evaluate competing perspectives and provide clear regulatory guidance. Applies regulatory and therapeutic area knowledge to Brand Team's…
  • 3.7
    Shockwave Medical – Fremont, CA
    EASY APPLY
    HOT
    conformance with applicable regulatory requirements to meet business objectives. The Director of Clinical Affairs will establish processes… Bachelor’s Degree in a scientific field of study. Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines…
  • 4.3
    Intuitive Surgical – Sunnyvale, CA
    $94k-$129k(Glassdoor est.)
    10 days ago 10d
    support development of scientific publications. Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g.,… support of business goals through Clinical Affairs activities Assist Clinical AffairsManager/Director for building departmental process…
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