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

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  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $95k-$142k
    27 days ago 27d
    collaboration with clinical sites, Clinical Operations, Regulatory Affairs and other stakeholders to ensure compliance with GCPs… conducted in accordance with the audit plan, GCP guidelines and regulatory requirements • Lead and co-audit US and international sites…
  • 4.2
    ZS Pharma – San Mateo, CA
    Est. Salary $97k-$137k
    6 days ago 6d
    Job Title: Manager, Commercial Regulatory Affairs Location: San Mateo About Us: ZS Pharma Inc., (an AstraZeneca… required 2-3+ years of relevant industry experience in Regulatory Affairs or related discipline, with an emphasis in the area of…
  • 4.4
    Coherus BioSciences – Redwood City, CA
    Est. Salary $62k-$128k
    8 days ago 8d
    programs. The Manager/Sr. Manager, Regulatory Affairs provides support to other Regulatory Affairs management in the day-to-day operational… Overview: The Manager/Sr. Manager, Regulatory Affairs supports the Companys regulatory activities across a variety of programs…
  • Bulletproof Documentation, Inc. – San Mateo, CA
    Est. Salary $66k-$162k
    12 days ago 12d
    variety of programs. The Manager/Sr. Manager, Regulatory Affairs provides support to other Regulatory Affairs management in the day-… our firm! Overview: The Manager/Sr. Manager, Regulatory Affairs supports the Companys regulatory activities across a variety…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $106k-$152k
    8 days ago 8d
    Biometrics, Regulatory Affairs, 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…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $117k-$160k
    30+ days ago 30d+
    processes within Regulatory Affairs relating to the promotion of Gilead products in the United States. The Manager is responsible… senior management in a timely manner. The Manager will assist senior Regulatory Affairs personnel in local process improvements…
  • Orchard Therapeutics Limited – Foster City, CA
    Est. Salary $147k-$245k
    21 days ago 21d
    requests for information from regulatory authorities - Train and mentor other regulatory affairs personnel As primary objective… year ago, it is in an exciting start-up phase where a Regulatory Affairs professional can have a real impact on the work and foundations…
  • 4.2
    Stanford University – Stanford, CA
    Est. Salary $82k-$127k
    1 days ago 15hr
    federal agencies, i.e. FDA. * Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical… seeking a Clinical Trials Regulatory and Quality Manager to be Responsible for the administration and regulatory oversight of clinical…
  • Kindred Biosciences, Inc. – Burlingame, CA
    Est. Salary $65k-$100k
    30+ days ago 30d+
    Job Description The European Regulatory Affairs Manager will oversee the regulatory activities of products in development through… Provide an assessment of regulatory opportunities to potentially enhance the development pathway and of regulatory risks for the various…
  • 4.2
    Clorox – Pleasanton, CA
    Est. Salary $84k-$116k
    27 days ago 27d
    As a Regulatory Affairs Specialist II in the Global Stewardship (GS) function you will work within a team of regulatory professionals… Corporate Quality, Marketing, Product Supply and Government Affairs. * Support a culture of curiosity, collaboration, critical…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $94k-$137k
    23 days ago 23d
    of regulatory affairs CMC strategy for investigational and commercial drugs. Communicate submission status and regulatory affairs… Work is performed under limited direction of a senior Regulatory Affairs professional. [1] https://regulatoryaffairs-careers.gilead.com…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $106k-$183k
    14 days ago 14d
    partners/stakeholders: Sales, Marketing, Market Access, Medical Affairs, etc. Follow all laws, regulations and policies that… initiatives Oversight of coordination with Legal, Medical, Regulatory and Corporate Training to ensure training deliverables are…
  • 3.5
    Abbott – Santa Clara, CA
    Est. Salary $71k-$103k
    7 days ago 7d
    continuing careers in Regulatory Affairs. • Ideal candidates will have no more than five years of regulatory affairs work experience… sponsorship. JOB DESCRIPTION: PRIMARY JOB FUNCTION: Our Regulatory Affairs Professional Development Program (RA PDP) is a mid-career-level…
  • 4.0
    Johnson & Johnson – Fremont, CA
    Est. Salary $119k-$190k
    20 days ago 20d
    CMC regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader… appropriately escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    14 days ago 14d
    partners/stakeholders: Sales, Marketing, Market Access, Medical Affairs, etc. Follow all laws, regulations and policies that… Leaders is preferred Strong understanding of legal and regulatory environment in pharmaceutical promotions, pharma industry…
  • 3.8
    Jazz Pharmaceuticals – Palo Alto, CA
    1 days ago 17hr
    according to company standards and processes; Manage the Global Regulatory Affairs contribution to overall company Records Information… to for records management as they pertain to Regulatory Affairs archives; Manage hard copy records storage by collaborating with…
  • 3.0
    Cepheid – Sunnyvale, CA
    24 days ago 24d
    analytical sections for regulatory submissions. * Interact with Regulatory Affairs and FDA or other regulatory and global (e.g. WHO… manually. JOB SUMMARY: Administer and supervise the Clinical Affairs department and external clinical review organization to monitor…
  • 3.2
    Gilead Sciences, Inc. – Foster City, CA
    Est. Salary $95k-$129k
    21 days ago 21d
    * Represent Regulatory Affairs on internal and external cross-functional teams, providing regulatory affairs support and strategy… local process improvements which have an impact on the Regulatory Affairs function and/or other departments. * As necessary,…
  • 3.4
    Real Staffing – Pleasanton, CA
    15 days ago 15d
    details! - 3-15 years of regulatory affairs experience (positions range from Sr. Specialist to Sr. Manager level, dependent upon… industry leaders in regulatory affairs recruitment within the CA Bay Area. We are currently seeking regulatory affairs candidates ranging…
  • 3.5
    Agilent Technologies – Santa Clara, CA
    6 days ago 6d
    partners,clinical and R&D scientists, Clinical Trial Managers and regulatory affairs 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…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $157k-$320k
    15 days ago 15d
    cross-functional departments including market research, legal, regulatory, medical affairs, payor marketing, corporate compliance, consumer… Lead projects through the legal, regulatory, and medical review process Develop and manage program budgets and develop metrics…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $73k-$100k
    26 days ago 26d
    meetings are chaired by a Regulatory Project Manager). -Act as a champion of the Regional CMC Regulatory viewpoint. -Work with… with RPTL to direct, manage and resolve CMC issues regarding the implementation of the global Regulatory CMC strategy. -Work with…
  • 2.9
    ZOLL Medical Corporation – San Jose, CA
    Est. Salary $103k-$150k
    6 days ago 6d
    Project Manager, Clinical Affairs in its San Jose Division. The position assists in the management of clinical affairs projects… studies. Responsibilities include collaborating with Clinical Affairs management in the implementation of various team and company…
  • 3.9
    Stanford School of Medicine – Stanford, CA
    Est. Salary $69k-$108k
    6 days ago 6d
    with federal agencies, i.e. FDA. • Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical… seeking a Clinical Trials Regulatory and Quality Manager to be Responsible for the administration and regulatory oversight of clinical…
  • 2.6
    Astex Pharmaceuticals – Pleasanton, CA
    Est. Salary $152k-$209k
    13 days ago 13d
    of CMC regulatory affairs experience is preferable, or BS/MS in life sciences with 10+ years of CMC regulatory affairs experience… Director, Global Regulatory Affairs - CMC will support oncology development programs, provide CMC regulatory expertise and support…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $143k-$235k
    27 days ago 27d
    research, legal, regulatory, medical affairs, segment marketing, corporate compliance, consumer marketing and IT Manage program budgets… patient support tactics Lead projects through the legal, regulatory, and medical review process Coordinate the work of multiple…
  • Chesapeake Consulting – Sunnyvale, CA
    22 days ago 22d
    Educators), commercial (marketing, sales, managed markets), health outcomes, regulatory, clinical development and safety as well… function as a scientific and medical resource for the Medical Affairs (MA) department at Company, as well as other groups across…
  • 4.4
    Ascent Services Group – Sunnyvale, CA
    Today 3hr
    Biometrics, Regulatory Affairs, 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. RESPONSIBILITIES…
  • 4.0
    Daimler – Sunnyvale, CA
    1 days ago 18hr
    brings hydrogen vehicles to the road. The Testing and Regulatory Affairs Division in Ann Arbor, MI and the Advanced Vehicle Design… field, or equivalent experience Highly organized and able to manage competing project priorities and constraints Excellent communication…
  • 3.0
    Cepheid – Sunnyvale, CA
    Est. Salary $257k-$408k
    30+ days ago 30d+
    Senior Director, Medical Affairs The Senior Director of Medical Affairs provides expertise on Cepheid assays and technology in… assist in writing articles for publication Engage with Clinical Affairs to optimize clinical trials activities Engage with Marketing…
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