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

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  • 3.9
    Planet Pharma – South San Francisco, CA
    7 days ago 7d
    stakeholders (including Quality Assurance and RegulatoryAffairs) to ensure supplies are labeled and released for clinical site shipment… aspects of clinical supply management including packaging, labeling, monitor inventory levels, and distribution by interacting with internal…
  • 3.2
    Dynavax Technologies – Berkeley, CA
    Est. Salary $201k-$266k
    11 days ago 11d
    duties as assigned. A BA/BS with 6+ years’ clinical regulatoryaffairs experience, with 2 years in a management role. The associate… content) and the final sign-off of regulatory submissions. Provide input to target labeling content (MDS, SmPC, US package insert…
  • 2.9
    Prothena – South San Francisco, CA
    Est. Salary $121k-$161k
    NEW
    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…
  • 3.7
    Bayside Solutions – Redwood City, CA
    EASY APPLY
    NEW
    overlooked and undertreated. The RegulatoryAffairsManager will be responsible for regulatory review of advertising and promotional… Bayside Solutions is seeking a RegulatoryAffairsManager (PRC) to be a part of our client's team in Redwood City. Our partner…
  • 5.0
    Intersect ENT – Menlo Park, CA
    Est. Salary $68k-$105k
    6 days ago 6d
    EXPERIENCE REQUIREMENTS: Minimum five years of regulatoryaffairs experience in the pharmaceutical and or medical device… Orders (CO). Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials…
  • 3.8
    Singulex – Alameda, CA
    Est. Salary $125k-$208k
    4 days ago 4d
    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…
  • 3.7
    Nektar Therapeutics – San Francisco, CA
    Est. Salary $177k-$260k
    12 days ago 12d
    projects. Drafts and reviews RegulatoryAffairs' SOPs. May participate in, and provide regulatory guidance to working teams (both… applicable for regulatory requirements (i.e., US, ICH). Reviews specifications, methods, SOPs, protocols, reports, labeling, and etc.…
  • 3.9
    Stryker – Fremont, CA
    Est. Salary $121k-$168k
    NEW
    Team. Communicates with regulatory agencies under the guidance of the RegulatoryAffairs Department Manager. Plans and executes meetings… Under general supervision of the RegulatoryAffairs Department Manager or Director Prepares complex submissions to gain approvals…
  • 4.5
    AirXpanders – Palo Alto, CA
    Est. Salary $76k-$113k
    21 days ago 21d
    include: Represent RegulatoryAffairs 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…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $68k-$99k
    5 days ago 5d
    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…
  • 3.5
    Relypsa Inc. – Redwood City, CA
    Est. Salary $91k-$132k
    5 days ago 5d
    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…
  • 4.4
    Ascent Services Group – Palo Alto, CA
    11 days ago 11d
    Senior ManagerRegulatoryAffairs Palo Alto, CA or Philadelphia, PA Permanent Responsibilities: Participate as… strategy scenarios Coordinate regulatory information as a team member, covering CMC, clinical, labeling, and post-approval change…
  • 4.0
    Genentech – South San Francisco, CA
    Est. Salary $94k-$173k
    11 days ago 11d
    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,…
  • 3.3
    Biomarin – Brisbane, CA
    Est. Salary $92k-$165k
    24 days ago 24d
    + years in RegulatoryAffairs. RegulatoryAffairs experience is essential with direct experience managing labeling submissions… related to labeling activities. Supporting launch and/or release of revised labeling into production. RegulatoryLabeling Strategy…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $90k-$123k
    11 days ago 11d
    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…
  • 4.4
    Ascent Services Group – San Rafael, CA
    NEW
    experience in RegulatoryAffairs or equivalent experience. Working knowledge of FDA and EU GMP and labeling regulations/Guidance… and managing electronic labeling files. Communicate with labelingmanagers to ensure any new regulatory requirements are incorporated…
  • 3.5
    Abbott – Alameda, CA
    Est. Salary $67k-$121k
    21 days ago 21d
    contributor, the function of a Senior RegulatoryAffairs Specialist is to provide support for the regulatory department to ensure efficient… contributor, the function of a Senior RegulatoryAffairs Specialist is to provide support for the regulatory department to ensure efficient…
  • 3.8
    Ghirardelli Chocolate – San Leandro, CA
    Est. Salary $49k-$80k
    NEW
    packaged goods or regulatoryaffairs. Working knowledge of FDA and USDA food labeling regulations, menu labeling laws, and documentation… to ensure regulatory requirements and technical accuracy with a high level of detail. Manage all phases of the label change process…
  • 3.3
    BioMarin Pharmaceutical – Brisbane, CA
    Est. Salary $91k-$162k
    26 days ago 26d
    years in RegulatoryAffairs. RegulatoryAffairs experience is essential with direct experience managing labeling submissions… : 209 RegulatoryAffairs Employment Type: FTE Location: United States - Brisbane, California Department: Regulatory & Pharmacovigilance…
  • Theravance Biopharma – South San Francisco, CA
    18 days ago 18d
    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…
  • 3.7
    Jazz Pharmaceuticals – Palo Alto, CA
    Est. Salary $149k-$199k
    25 days ago 25d
    The Associate Director RegulatoryAffairsLabeling will be responsible for regulatory support (both technical and operational)… experience in regulatoryaffairs with particular focus on labeling Experience associated with global product labeling regulations…
  • 3.5
    Relypsa, Inc. – Redwood City, CA
    Est. Salary $139k-$184k
    24 days ago 24d
    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…
  • PRO Unlimited @ BioMarin – San Rafael, CA
    EASY APPLY
    28 days ago 28d
    years experience in RegulatoryAffairs or equivalent experience. Working knowledge of FDA and EU GMP and labeling regulations/Guidance… and managing electronic labeling files. Communicate with labelingmanagers to ensure any new regulatory requirements are incorporated…
  • 4.0
    Genentech – South San Francisco, CA
    5 days ago 5d
    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
    Gilead Sciences – Foster City, CA
    Est. Salary $110k-$163k
    19 days ago 19d
    industry experience is preferred. 10+ years of experience in RegulatoryAffairs or relevant industry experience following a Bachelor’s… experience working with regional chemistry reviewers. RegulatoryAffairs Certification, a plus. Previous management experience,…
  • 3.1
    Theravance – South San Francisco, CA
    19 days ago 19d
    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…
  • 4.0
    Genentech – South San Francisco, CA
    Est. Salary $49k-$68k
    NEW
    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
    Natera – San Carlos, CA
    Est. Salary $156k-$210k
    6 days ago 6d
    customers and regulatory authorities surrounding regulatory pathway, performance claims, supporting data, and labeling (including… SUMMARY The Director, RegulatoryAffairs leads, plans, coordinates, conducts and reports on regulatory registration programs.…
  • 3.9
    Stryker Corporation – Fremont, CA
    Est. Salary $121k-$168k
    5 days ago 5d
    . Communicates with regulatory agencies under the guidance of the RegulatoryAffairs Department Manager. Plans and executes meetings… Under general supervision of the RegulatoryAffairs Department Manager or Director Prepares complex submissions to gain approvals…
  • 3.9
    Planet Pharma – San Francisco, CA
    Est. Salary $52k-$79k
    21 days ago 21d
    Letters of Authorization and product label reviews . Under the direction of senior regulatoryaffairs staff, provides input on timelines… Category: RegulatoryAffairs Industry: Biotechnology Duties: Responsible for supporting the Regulatory Affairs…
  • 3.9
    Planet Pharma – San Francisco, CA
    Est. Salary $129k-$172k
    21 days ago 21d
    Category: RegulatoryAffairs Responsible for oversight of all regulatory activities of regulatory team. Develops… adequate to provide RegulatoryAffairs support for company projects. Interacts with (senior level) regulatory personnel at partner…
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