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

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  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $155k-$212k
    23 days ago 23d
    highly beneficial. Minimum of 7+ years of relevant Regulatory Affairs, Advertising and Promotional Materials experience in the… and US labeling, prior experience in oncology or hematology drugs strongly preferred. Experience in the regulatory review…
  • 4.5
    AirXpanders – Palo Alto, CA
    Est. Salary $76k-$112k
    22 days ago 22d
    include: Represent Regulatory Affairs on product development project teams to ensure all regulatory requirements are met throughout… and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings globally…
  • 3.8
    Bayside Solutions – Redwood City, CA
    2 days ago 2d
    overlooked and undertreated. The Regulatory Affairs Manager will be responsible for regulatory review of advertising and promotional… Bayside Solutions is seeking a Regulatory Affairs Manager (PRC) to be a part of our client's team in Redwood City. Our partner…
  • 3.9
    Jazz Pharmaceuticals – Palo Alto, CA
    Est. Salary $149k-$203k
    23 days ago 23d
    The Associate Director Regulatory Affairs Labeling will be responsible for regulatory support (both technical and operational… experience in regulatory affairs with particular focus on labeling Experience associated with global product labeling regulations…
  • 3.5
    Abbott – Santa Clara, CA
    Est. Salary $68k-$124k
    12 days ago 12d
    contributor, the function of a Senior Regulatory Affairs 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…
  • 3.5
    Abbott – Santa Clara, CA
    Est. Salary $68k-$97k
    27 days ago 27d
    contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient… preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 2-3 years’ experience in a regulated…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $223k-$356k
    9 days ago 9d
    investigational new drug) applications and filings.Supports Regulatory Affairs on clinical development aspects of filings; plays a central… interactions with little or no supervision from his/her manager Works with Regulatory and other partners/stakeholders in the completion…
  • 3.9
    Stryker – Fremont, CA
    Est. Salary $117k-$162k
    6 days ago 6d
    Team. Communicates with regulatory agencies under the guidance of the Regulatory Affairs Department Manager. Plans and executes meetings… Information Under general supervision of the Regulatory Affairs Department Manager or Director Prepares complex submissions…
  • 1.0
    Absolute Opportunities – Santa Clara, CA
    Est. Salary $89k-$142k
    12 days ago 12d
    Senior Regulatory Affairs Specialist - RT Santa Clara, California 95052 Senior Regulatory Affairs Specialist -… and laws • Review labeling and labels for compliance with regulatory requirements • Provide the regulatory reviews of customer…
  • 3.5
    Relypsa Inc. – Redwood City, CA
    Est. Salary $100k-$143k
    7 days ago 7d
    Summary: The Manager, Regulatory Affairs will have broad Regulatory responsibilities and serve as the regulatory lead for designated… documentation (i.e., quality, safety, efficacy, and labeling) to be included in regulatory submissions (e.g., IND, CTA, NDA, MAA) for accuracy…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $223k-$356k
    28 days ago 28d
    investigational new drug) applications and filings. Supports Regulatory Affairs on clinical development aspects of filings; plays a central… interactions with little or no supervision from his/her manager · Works with Regulatory and other partners/stakeholders in the completion…
  • 4.8
    23andMe, Inc. – Mountain View, CA
    Est. Salary $77k-$111k
    11 days ago 11d
    continuous improvements for Regulatory Affairs and in support of the quality system Manage regulatory documentation (e.g., technical… . What youll do The Regulatory Affairs Specialist is an integral member of the Regulatory Affairs team. In this role, you…
  • 3.2
    Thermo Fisher Scientific – San Jose, CA
    Est. Salary $188k-$256k
    9 days ago 9d
    medical device regulatory affairs function and activities, including device, labeling and promotional reviews, regulatory submissions… areas of focus. Manages multiple departments responsible for quality systems, product quality, regulatory affairs and document control…
  • 3.5
    Relypsa Inc. – Redwood City, CA
    Est. Salary $151k-$205k
    27 days ago 27d
    Participate on Regulatory Affairs sub teams for activities related to the development of labeling for regulatory submissions.… The Associate Director, Regulatory Affairs will be responsible for performing or managing key regulatory activities for the department…
  • 4.2
    ZELTIQ Aesthetics – Pleasanton, CA
    Est. Salary $90k-$137k
    13 days ago 13d
    countries) • Reviews proposed product changes, labels and labeling material for regulatory impact • Determines governmental regulations… Qualifications: • BS or BA degree plus 4-6 years experience in regulatory affairs with more than 2 years in medical devices preferred. Additional…
  • 3.2
    Gilead Sciences, Inc. – Foster City, CA
    Est. Salary $72k-$100k
    5 days ago 5d
    Final Review and Approval of regional label. -Coordinate the provision of global Regulatory CMC advice to PDM, QA and Commercial… meetings are chaired by a Regulatory Project Manager). -Act as a champion of the Regional CMC Regulatory viewpoint. -Work with…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $111k-$192k
    20 days ago 20d
    stakeholders: Sales, Marketing, Market Access, Medical Affairs, etc. Follow all laws, regulations and policies that govern… ensure messages provided are approved and consistent with our label Communicate and collaborate with internal partners/stakeholders…
  • 3.5
    Abbott – Santa Clara, CA
    Est. Salary $105k-$143k
    15 days ago 15d
    contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to… is recognized as a discipline expert and resource in regulatory affairs. Influence/Leadership: · Develops, communicates, and…
  • 2.4
    Kofax – Pleasanton, CA
    Est. Salary $103k-$158k
    26 days ago 26d
    The Regulatory Affairs Manager (RA) will interface with the top management to ensure that the Quality Management System requirements… Manages the internal audit and corrective/preventive action programs Reviews design documentation, product labelling and…
  • 4.0
    Boston Scientific – Los Gatos, CA
    8 days ago 8d
    Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance. Key… discipline required. Advanced degree preferred. 3+ years Regulatory Affairs medical industry experience required; specific medical…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    20 days ago 20d
    partners/stakeholders: Sales, Marketing, Market Access, Medical Affairs, etc. Follow all laws, regulations and policies that… Pharmacyclics speaker presentation content; provide further on-label and PRC-approved education and guidance to speakers to ensure…
  • AstraZeneca Pharmaceuticals LP – Redwood City, CA
    6 days ago 6d
    smaller global function such as CMC, regulatory affairs directors, associate directors and managers, managing health authority relationships… Works collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing…
  • 3.2
    Gilead Sciences, Inc. – Foster City, CA
    Est. Salary $109k-$161k
    19 days ago 19d
    experience is preferred. 10+ years of experience in Regulatory Affairs or relevant industry experience following a Bachelor's… experience working with regional chemistry reviewers. Regulatory Affairs Certification, a plus. Previous management experience…
  • 3.6
    CooperVision – Pleasanton, CA
    6 days ago 6d
    Years of experience 2-5 w/Bachelors; 0-2 w/Masters Regulatory Affairs Certification, preferred. EXPERIENCE Working… and regulatory requirements. The Global Regulatory Compliance Specialist will report directly to the Senior Manager of…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $67k-$97k
    20 days ago 20d
    and considering the regulatory requirements, recommends appropriate courses of action. Reviews labels, labeling, and promotional… and policies. Provides regulatory opinions on premarket regulatory requirements, export, and labeling requirements. This role…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $96k-$162k
    21 days ago 21d
    is currently seeking a Manager/Associate Director of Regulatory Affairs. The Manager, Regulatory Affairs is responsible and accountable… premarket submissions and Technical Files. Manages the regulatory review of labels, labeling, and promotional materials. Hires, develops…
  • 3.2
    Astellas – Redwood City, CA
    1 days ago 21hr
    smaller global function such as CMC, regulatory affairs directors, associate directors and managers, managing health authority relationships… Works collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing…
  • 2.9
    Safeway Inc. – Dublin, CA
    12 days ago 12d
    as directed by Regulatory Management. These activities include all documentation, label development and label proofing for our… • There is no degree available in the field of Food Regulatory Affairs and the skills necessary to be successful in this role…
  • 3.6
    AstraZeneca – Redwood City, CA
    19 days ago 19d
    smaller global function such as CMC, regulatory affairs directors, associate directors and managers, managing health authority relationships… Works collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing…
  • 3.7
    AbbVie – Redwood City, CA
    Est. Salary $148k-$256k
    Today 11hr
    including: Translational Research, Clinical Development, Regulatory Affairs, Market Research, Market Access, HEOR, Forecasting, Finance… Finance, Regional and Affiliate Marketing, Medical Affairs, Licensing and Acquisitions and Business Development. This position…
  • 3.6
    AstraZeneca – Redwood City, CA
    30+ days ago 30d+
    smaller global function such as CMC, regulatory affairs directors, associate directors and managers, managing health authority relationships… Works collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing…
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