Regulatory Affairs Manager - Labeling Jobs in San Francisco, CA | Glassdoor
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Regulatory Affairs Manager - Labeling Jobs in San Francisco, CA

31 Jobs

  • 3.2
    Gilead Sciences – Foster City, CA
    $90k-$123k(Glassdoor est.)
    14 days ago 14d
    for preparing regulatory submissions which require interactions with departments outside of RegulatoryAffairs for investigational… which have a significant impact on the working of the RegulatoryAffairs function or other departments. Excellent organization…
  • 3.3
    Relypsa, Inc. – Redwood City, CA
    $132k-$177k(Glassdoor est.)
    NEW
    Facilitate Labeling Review Committee activities. Participate on RegulatoryAffairs sub teams for activities related… The Associate Director, RegulatoryAffairs will be responsible for performing or managing key regulatory activities for the department…
  • 3.5
    Singulex – Alameda, CA
    $126k-$209k(Glassdoor est.)
    7 days ago 7d
    degree preferred or a focused degree in RegulatoryAffairs. 10+ years related regulatory experience In-vitro diagnostic (reagents… leadership skills and experience in managing a department of RegulatoryAffairs professionals. Further, the candidate will have extensive…
  • 3.2
    Prothena – South San Francisco, CA
    $128k-$172k(Glassdoor est.)
    6 days ago 6d
    with the Director of RegulatoryAffairs and global regulatory team towards the development of global regulatory strategies Provide… objectives, the Associate Director of RegulatoryAffairs will be responsible for developing regulatory strategies, planning, managing…
  • 3.2
    Actelion – San Francisco, CA
    $206k-$325k(Glassdoor est.)
    NEW
    Phase IV program. Manage and oversee investigator initiated studies program. Partner with RegulatoryAffairs on NDA annual reports… the Directors, Associate Directors and/or managers in Medical Affairs and Clinical Operations. Responsible for the development…
  • 3.2
    Gilead Sciences – Foster City, CA
    $113k-$155k(Glassdoor est.)
    NEW
    communication among various RegulatoryAffairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion… in RegulatoryAffairs. Ten to twelve years of relevant experience are required; experience in both RegulatoryAffairs and…
  • 3.2
    Biomarin – San Rafael, CA
    $131k-$178k(Glassdoor est.)
    NEW
    related experience with at least 5 years of experience in RegulatoryAffairs in the biotechnology or pharmaceutical industries, including… globally. Provides regulatory leadership on cross-functional development teams. Manages and mentors regulatory professionals to…
  • 4.6
    PSC Biotech – Alameda, CA
    7 days ago 7d
    required but training and certificates in quality or regulatoryaffairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma… Responsible for being a Product Labeling representative on new product development teams, help to managelabeling projects, and be responsible…
  • 4.0
    Genentech – South San Francisco, CA
    $181k-$274k(Glassdoor est.)
    14 days ago 14d
    Position Commercial RegulatoryAffairs (CORA) is part of the broader Product Development Regulatory (PDR) organization that… development of cross-functional regulatory strategies; ensuring provision of commercial regulatoryaffairs expertise, insights, perspective…
  • 3.5
    Abbott – Alameda, CA
    $168k-$226k(Glassdoor est.)
    28 days ago 28d
    The function of Director, RegulatoryAffairs is to combine knowledge of scientific, regulatory and business issues to enable… and procedures for regulatoryaffairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles…
  • 3.1
    Natera – San Carlos, CA
    $158k-$213k(Glassdoor est.)
    24 days ago 24d
    SUMMARY The Director, RegulatoryAffairs leads, plans, coordinates, conducts and reports on regulatory registration programs.… customers and regulatory authorities surrounding regulatory pathway, performance claims, supporting data, and labeling (including…
  • 3.2
    Halozyme Therapeutics, Inc. – San Francisco, CA
    $205k-$324k(Glassdoor est.)
    9 days ago 9d
    U.S. healthcare landscape (managed markets, emergence of evidence based medicine, current regulatory environment, etc.) for appropriate… kick-off slides Provide input to all rounds of label reviews and participate in label negotiation calls with partners Provide input…
  • 3.3
    Amyris – Emeryville, CA
    7 days ago 7d
    essential role, reporting to the Director Scientific and RegulatoryAffairs, will be responsible for developing dossiers supporting… environmental and food additives regulatory agencies. The Regulatory Product Stewardship Coordinator will collaborate with the Amyris…
  • 3.2
    BioMarin Pharmaceutical – San Rafael, CA
    $111k-$230k(Glassdoor est.)
    17 days ago 17d
    to the labeling team and cross functional teams where Reg labeling membership is required. Manage the strategic regulatory labeling… 209 RegulatoryAffairs Employment Type: FTE Location: United States - San Rafael, California Department: Regulatory & Pharmacovigilance…
  • 3.2
    Dynavax Technologies – Berkeley, CA
    $95k-$175k(Glassdoor est.)
    10 days ago 10d
    (CAPA’s). Work closely with RegulatoryAffairs to assess changes and exceptions for regulatory impact, and to assure appropriate… to, non-conforming products, complaints, regulatory inspections, etc. Notify manager appropriately and propose feasible solution…
  • 3.3
    Relypsa Inc. – Redwood City, CA
    $86k-$123k(Glassdoor est.)
    8 days ago 8d
    Summary: The Manager, RegulatoryAffairs 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…
  • 3.6
    Abbott Laboratories – Alameda, CA
    $200k-$267k(Glassdoor est.)
    30+ days ago 30d+
    The function of Director, RegulatoryAffairs is to combine knowledge of scientific, regulatory and business issues to enable… procedures for regulatoryaffairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles…
  • 4.0
    Genentech – South San Francisco, CA
    $97k-$174k(Glassdoor est.)
    21 days ago 21d
    Position Commercial RegulatoryAffairs (CORA) is part of the broader Product Development Regulatory (PDR) organization that… legal, clinical affairs, regulatory and product marketing) as well as working knowledge of the legal and regulatory environment,…
  • 3.2
    Gilead Sciences – Foster City, CA
    $105k-$144k(Glassdoor est.)
    15 days ago 15d
    Quality Assurance, Packaging & Labeling, Materials Management, Outsourcing, RegulatoryAffairs, Commercial Manufacturing, and… biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements Experience should include 3 years of participation…
  • 4.0
    Genentech – South San Francisco, CA
    $65k-$107k(Glassdoor est.)
    4 days ago 4d
    reports as well as safety support and direction for US Medical Affairs sponsored and supported interventional and non-interventional… the CMT Head. Demonstrates understanding of appropriate labeling documents of Genentech/ Roche molecules and products. Accountable…
  • 3.1
    Theravance – South San Francisco, CA
    21 days ago 21d
    Director, RegulatoryAffairs at Theravance Biopharma (View all jobs) South San Francisco Job Purpose The Regulatory Affairs… contributions to department and company initiatives related to regulatoryaffairs operations and strategy. Duties and Responsibilities…
  • Theravance Biopharma – South San Francisco, CA
    21 days ago 21d
    Director, RegulatoryAffairs at Theravance Biopharma (View all jobs) South San Francisco Job Purpose The Regulatory Affairs… Experience in the management of core labeling and/or US labeling Understanding of regulatory requirements for and experience with…
  • 3.8
    Orchard Therapeutics Limited – Foster City, CA
    $88k-$162k(Glassdoor est.)
    NEW
    Reporting to: Senior Vice President, Quality Assurance and RegulatoryAffairs The Orchard Therapeutics team based in Foster City… coordination, and management of regulatory agency Preapproval or regular inspections. Support regulatory inspections; internal and…
  • AstraZeneca Pharmaceuticals LP – Redwood City, CA
    7 days ago 7d
    smaller global function such as CMC, regulatoryaffairs directors, associate directors and managers, managing health authority relationships… Works collaboratively with the global/regional/local regulatoryaffairs staff at Acerta and AstraZeneca, to influence developing…
  • 3.6
    AstraZeneca – Redwood City, CA
    20 days ago 20d
    smaller global function such as CMC, regulatoryaffairs directors, associate directors and managers, managing health authority relationships… Works collaboratively with the global/regional/local regulatoryaffairs staff at Acerta and AstraZeneca, to influence developing…
  • 3.8
    Orchard Therapeutics – Foster City, CA
    EASY APPLY
    $88k-$162k(Glassdoor est.)
    4 days ago 4d
    Reporting to: Senior Vice President, Quality Assurance and RegulatoryAffairs The Orchard Therapeutics team based in Foster City… to the Senior Vice President of Quality Assurance and RegulatoryAffairs and will be a key asset in the set-up of the Quality Department…
  • 4.0
    Genentech – South San Francisco, CA
    8 days ago 8d
    intended for the managed markets and payer environment As assigned, act as a member of U.S. Medical Affairs (USMA) Medical Teams… organize medical communications for launch of new products and/or label extensions Good analytical and problem-solving capabilities…
  • 3.2
    BioMarin Pharmaceutical Inc. – Novato, CA
    $112k-$174k(Glassdoor est.)
    NEW
    if required; working with Logistics, RegulatoryAffairs, CLO and CRO Ensure Regulatory green light as well as technical green… EC, RA, protocol amendments, expiry dating, country-specific labels) and communicate progress to various team members such as CMO…
  • 3.6
    AstraZeneca – Redwood City, CA
    30+ days ago 30d+
    smaller global function such as CMC, regulatoryaffairs directors, associate directors and managers, managing health authority relationships… Works collaboratively with the global/regional/local regulatoryaffairs staff at Acerta and AstraZeneca, to influence developing…
  • 3.3
    Del Monte Foods – Walnut Creek, CA
    $138k-$175k(Glassdoor est.)
    24 days ago 24d
    & Food Safety and/or regulatory areas. With advanced degree, minimum 4 years with Q&FS and/or regulatory area. Professional… methodologies as required by Corporate QA. Support Consumer Affairs requests for information or forward to appropriate area of…
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