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Regulatory Affairs Manager Jobs in Santa Clara, CA

197Jobs

  • East Bay Community Energy – Hayward, CA
    16 days ago 16d
    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…
  • 4.3
    Ascent Services Group – Pleasanton, CA
    NEW
    of CMC regulatoryaffairs experience is preferable, or BS/MS in life sciences with 10+ years of CMC regulatoryaffairs experience… Senior Director Global RegulatoryAffairs CMC East San Francisco Bay Area Permanent Responsibilities: Work closely…
  • 3.7
    Agilent Technologies – Santa Clara, CA
    25 days ago 25d
    partners,clinical and R&D scientists, Clinical Trial Managers and regulatoryaffairs to assure compliance with internal and external… Clinical Affairs Scientist to work within the exciting field of oncology Companion Diagnostics (CDx). As a Clinical Affairs Scientist…
  • 3.5
    Abbott – Santa Clara, CA
    23 days ago 23d
    function of an Associate Director RegulatoryAffairs is to combine knowledge of scientific, regulatory and business issues to enable… Individual is recognized as an industry expert and resource in regulatoryaffairs. Develops, communicates, and builds consensus for operating…
  • 3.5
    Abbott – Santa Clara, CA
    15 days ago 15d
    Review Board. Represent clinical affairs during post-market surveillance and to regulatory agencies as part of the pre-market… approximately 4 in clinical affairs. Reports to the Director, Clinical Affairs for Hematology. The Manager has business unit-wide…
  • 3.1
    Gilead Sciences – Foster City, CA
    $90k-$123k(Glassdoor est.)
    9 days ago 9d
    communication among various RegulatoryAffairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising… in RegulatoryAffairs. Five to seven years of relevant experience are required; ideally experience in both Regulatory Affairs…
  • 2.0
    Optra Health – Sunnyvale, CA
    $101k-$138k(Glassdoor est.)
    24 days ago 24d
    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…
  • 3.1
    International Technological University – San Jose, CA
    EASY APPLY
    $49k-$71k(Glassdoor est.)
    NEW
    Student Affairs and Services is responsible for the overall functioning and performance of the Department of Student Affairs and Services… policies, procedures and regulatory requirements. Works with the Assistant Provost, department chairs, managers and supervisors to…
  • 4.0
    Stryker – San Jose, CA
    HOT
    Internship - Regulatory - California Group Corporate Division Corporate Business Function RegulatoryAffairs Country… Engineering, Supplier Quality, Marketing, and Clinical Affairs to assist in regulatory decision-making and develop a broad understanding…
  • 4.1
    Jazz Pharmaceuticals – Palo Alto, CA
    $158k-$212k(Glassdoor est.)
    30+ days ago 30d+
    Profile The Associate Director RegulatoryAffairs Labeling will be responsible for regulatory support (both technical and operational… effectiveness of the label review process Work closely with RegulatoryAffairs colleagues and Supply chain colleagues Provide project…
  • 2.0
    Pharmacyclics – Sunnyvale, CA
    $130k-$176k(Glassdoor est.)
    HOT
    Clinical Science, Safety Science, Biometrics, Regulatory, Quality, Commercial, Medical Affairs, or Clinical Operations is preferred.… developing an understanding of the scientific, clinical, regulatory, commercial, and strategic context of the meeting topics;…
  • 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…
  • 2.8
    Agilent Technologies UK Ltd – Santa Clara, CA
    14 days ago 14d
    partners,clinical and R & D scientists, Clinical Trial Managers and regulatoryaffairs to assure compliance with internal and external… Clinical Affairs Scientist to work within the exciting field of oncology Companion Diagnostics (CDx). As a Clinical Affairs Scientist…
  • 3.5
    Ardelyx – Fremont, CA
    $69k-$100k(Glassdoor est.)
    19 days ago 19d
    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…
  • 3.1
    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…
  • 4.0
    Stryker – San Jose, CA
    $67k-$106k(Glassdoor est.)
    10 days ago 10d
    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…
  • 4.0
    Stanford School of Medicine – Stanford, CA
    $119k-$174k(Glassdoor est.)
    5 days ago 5d
    in a dynamic research setting. Strong knowledge of regulatoryaffairs, including FDA regulations, IRB review and approval process… committees. May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project…
  • 3.1
    Gilead Sciences – Foster City, CA
    $115k-$207k(Glassdoor est.)
    12 days ago 12d
    and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough… Foster City, CA location: Position: Senior Manager, HCV Medical Affairs Responsibilities: Serve as an information…
  • 4.0
    Stanford School of Medicine – Stanford, CA
    5 days ago 5d
    clinical trials regulatory requirements, or experience working with an IRB. Knowledge of regulatoryaffairs, including FDA… materials required for regulatory submissions in compliance with University and external policies. Manage and oversee new study…
  • 3.1
    Cepheid – Sunnyvale, CA
    $228k-$359k(Glassdoor est.)
    8 days ago 8d
    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…
  • 4.4
    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…
  • 4.3
    Ascent Services Group – Pleasanton, CA
    14 days ago 14d
    years of regulatoryaffairs experience is preferable, or BS/MS in life sciences with 8+ years of regulatoryaffairs experience… Associate Director/Director, Global RegulatoryAffairs Pleasanton, CA Permanent Responsibilities: Will support…
  • 2.0
    Pharmacyclics – Sunnyvale, CA
    24 days ago 24d
    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…
  • 3.1
    Gilead Sciences – Foster City, CA
    NEW
    strategic plans consistent with the Therapeutic Area Medical Affairs Plan of Action (POA). Collaborates effectively and in a compliant… for information, consistent with promotional compliance and regulatory requirements. Coaches, oversees and conducts performance…
  • 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…
  • 4.0
    Stryker Corporation – Fremont, CA
    $131k-$178k(Glassdoor est.)
    30+ days ago 30d+
    . Communicates with regulatory agencies under the guidance of the RegulatoryAffairs Department Manager. Plans and executes meetings… Description Under general supervision of the RegulatoryAffairs Department Manager or Director Prepares complex submissions…
  • 4.0
    Stryker Corporation – Fremont, CA
    $101k-$139k(Glassdoor est.)
    30+ days ago 30d+
    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…
  • 3.9
    Boston Scientific – San Jose, CA
    22 days ago 22d
    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…
  • 4.3
    Ascent Services Group – Menlo Park, CA
    10 days ago 10d
    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…
  • 3.9
    NeoTract – Pleasanton, CA
    5 days ago 5d
    Engineering, RegulatoryAffairs, and field personnel to ensure compliance with laws, regulations, and regulatory directives at… complaint handling system and communication/reporting to regulatory authorities. Lead the development of operational policies…
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