Associate Director, Regulatory Affairs Submissions Jobs in South San Francisco, CA | Glassdoor
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Associate Director, Regulatory Affairs Submissions Jobs in South San Francisco, CA

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  • 3.7
    NGM Biopharmaceuticals – South San Francisco, CA
    Est. Salary $73k-$113k
    25 days ago 25d
    Responsible for working closely with the Associate Director, Regulatory Affairs to develop regulatory strategies for therapeutic candidates… management of regulatory submissions including authoring and preparing regulatory documentation. Provide regulatory assistance…
  • 3.7
    Singulex – Alameda, CA
    Est. Salary $123k-$208k
    2 days ago 2d
    degree preferred or a focused degree in Regulatory Affairs. 10+ years related regulatory experience In-vitro diagnostic (reagents… requiring regulatory agency approval, as pertains to US and international regulatory requirements. Manage submission activities…
  • 5.0
    MyoKardia – South San Francisco, CA
    Est. Salary $53k-$122k
    1 days ago 1d
    report to the Head of Regulatory Affairs. ESSENTIAL DUTIES & RESPONSIBILITIES: • Develop and implement regulatory strategies to facilitate… to market our products. The individual will represent Regulatory Affairs and work closely with cross-functional teams and development…
  • 2.8
    Five Prime Therapeutics, Inc. – South San Francisco, CA
    Est. Salary $122k-$166k
    22 days ago 22d
    cross-functional teams. This is an Associate Director level role reporting to the Vice President of Regulatory Affairs. Responsibilities… policies for Regulatory Affairs. Provide regulatory expertise and policy support; educate others on regulatory policy and environment…
  • 3.4
    Biomarin – San Rafael, CA
    Est. Salary $164k-$222k
    3 days ago 3d
    preparation, and submission of marketing applications to support LATAM, MEA CIS and APAC regions * Provide strategic regulatory insight… Provides regulatory leadership on cross-functional development teams. Manages and mentors associate-level regulatory professionals…
  • 4.5
    Achaogen – South San Francisco, CA
    EASY APPLY
    Est. Salary $162k-$221k
    19 days ago 19d
    the position of Director of Regulatory Affairs, reporting directly to the Head of Regulatory Affairs. The Director will provide global… investigator brochures, responses to regulatory agencies and all regulatory submissions. Provide regulatory expertise for development of…
  • 3.8
    On Lok SeniorHealth – San Francisco, CA
    Est. Salary $48k-$73k
    6 days ago 6d
    TITLE: REGULATORY AFFAIRS SPECIALIST (PROVIDER) POSITION SUMMARY: Under the direction and supervision of the Director of Regulatory… Regulatory Affairs and Compliance, the Regulatory Affairs Specialist helps to ensure On Lok Senior Health Services remains compliant…
  • 2.5
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $116k-$160k
    3 days ago 3d
    Opportunity The Associate Director/Director, Regulatory Affairs (Device) will be responsible for managing all regulatory aspects for… required. At least 3 years of regulatory affairs with experience associated with global submissions. Must have comprehensive understanding…
  • 3.8
    Stryker – Fremont, CA
    Est. Salary $117k-$162k
    7 days ago 7d
    general supervision of the Regulatory Affairs Department Manager or Director Prepares complex submissions to gain approvals for… with in-country Regulatory Affairs personnel to facilitate global clearances/approvals. Develops global regulatory strategies for…
  • 4.0
    Genentech – South San Francisco, CA
    Est. Salary $94k-$170k
    10 days ago 10d
    into the Head of U.S. Regulatory Affairs and is focused on the U.S. Market. Associate Program Directors of Program Review Committees… Hiring / Find A Job Associate Program Director, Regulatory South San Francisco, California United States…
  • 3.5
    Relypsa Inc. – Redwood City, CA
    Est. Salary $151k-$205k
    24 days ago 24d
    Summary: The Associate Director, Regulatory Affairs will be responsible for performing or managing key regulatory activities for… Participate on Regulatory Affairs sub teams for activities related to the development of labeling for regulatory submissions.…
  • 3.8
    On Lok SeniorHealth – San Francisco, CA
    Est. Salary $48k-$73k
    6 days ago 6d
    direction and supervision of the Director of Regulatory Affairs and Compliance, the Regulatory Affairs Specialist helps to ensure On… Department of Managed Health Care (DMHC). The Regulatory Affairs Specialist performs regulatory activities and implements monitoring initiatives…
  • 3.2
    Scientific Search – San Francisco, CA
    Est. Salary $62k-$97k
    12 days ago 12d
    Responsible for working closely with the Associate Director, Regulatory Affairs to develop regulatory strategies for therapeutic candidates… Manager of Regulatory Affairs BIOLOGICS EXPERIENCE REQUIRED! Our client is searching for a Manager of Regulatory Affairs who will…
  • 2.5
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $128k-$176k
    3 days ago 3d
    required. At least 3 years of regulatory affairs with experience associated with global submissions. Must have comprehensive understanding… Opportunity The Director, Regulatory Affairs (Early Development) will be responsible for managing all regulatory aspects (Nonclinical…
  • 2.5
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $88k-$208k
    18 days ago 18d
    At least 4 years of regulatory affairs with experience associated with leading NDA and global submissions. • Must have comprehensive… key member of our diverse regulatory affairs team, the Director/Senior Director, Regulatory Affairs will be responsible for developing…
  • 5.0
    MyoKardia, Inc. – South San Francisco, CA
    7 days ago 7d
    • Liaise with clinical operations, virtual PV vendor, regulatory affairs, clinical research organizations (CROs) and data management… outstanding queries are resolved and closed • Review regulatory submissions to ensure procedural compliance and to assess the medical…
  • 3.5
    AstraZeneca – Redwood City, CA
    30+ days ago 30d+
    of smaller global function such as CMC, regulatory affairs directors, associate directors and managers, managing health authority… Works collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $162k-$258k
    11 days ago 11d
    The Senior Director, Global Medical Affairs, HEM-ONC will report into the Senior Vice President of Medical Affairs. Below outlines… and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $96k-$162k
    18 days ago 18d
    currently seeking a Manager/Associate Director of Regulatory Affairs. The Manager, Regulatory Affairs is responsible and accountable… risks and mitigations associated with regulatory strategies to stakeholders. Represents Regulatory Affairs function in interactions…
  • Theravance Biopharma – South San Francisco, CA
    11 days ago 11d
    Clinical Pharmacology, Development and Operations, and Regulatory Affairs) to meet project timelines and goals. Manage and operate… development reports, and reports from CSPs. Support regulatory submissions by drafting and reviewing drug product sections of INDs…
  • 3.1
    Theravance – South San Francisco, CA
    Est. Salary $132k-$227k
    10 days ago 10d
    Clinical Pharmacology, Development and Operations, and Regulatory Affairs) to meet project timelines and goals. Manage and operate… development reports, and reports from CSPs. Support regulatory submissions by drafting and reviewing drug product sections of INDs…
  • 2.5
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $74k-$109k
    11 days ago 11d
    representing Regulatory Affairs and foster positive and productive working relationships between project team members and regulatory agency… Prepare departmental guidelines for Regulatory Affairs and communicate new regulatory requirements across the company as appropriate…
  • 4.3
    Ascent Services Group – Redwood City, CA
    10 days ago 10d
    new drug) applications and filings. Supports Regulatory Affairs on clinical development aspects of filings; plays a central role… her manager Works with Regulatory and other partners/stakeholders in the completion and submission of IND (investigational new…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $162k-$258k
    27 days ago 27d
    and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough… Safety Committee • Provide input into clinical data for regulatory submissions as requested by Project Team Commercial support…
  • Theravance Biopharma US, Inc. – South San Francisco, CA
    15 days ago 15d
    development reports, and reports from CSPs. • Support regulatory submissions by drafting and reviewing drug product sections of INDs… Clinical Pharmacology, Development and Operations, and Regulatory Affairs) to meet project timelines and goals. • Manage and operate…
  • 2.5
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $55k-$97k
    25 days ago 25d
    relationships with internal stakeholders within QC, QA, Regulatory Affairs, Development, Manufacturing and with external customers… ultimate success. Your Opportunity The Senior Manager/Associate Director, Stability Commercial QC will be responsible for the overall…
  • 4.3
    Ascent Services Group – San Francisco, CA
    9 days ago 9d
    Clinical Science, Clinical Operations, Regulatory Affairs, Quality Assurance, Medical Affairs/Medical Information and external partners… documents, including NDA/MAA submission safety documents, periodic reports and responses to regulatory questions. All activities…
  • 3.2
    Gilead Sciences, Inc. – Foster City, CA
    Est. Salary $162k-$258k
    11 days ago 11d
    The Senior Director, Global Medical Affairs, HEM-ONC will report into the Senior Vice President of Medical Affairs. Below outlines… and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough…
  • 3.4
    BioMarin Pharmaceutical – San Rafael, CA
    Est. Salary $108k-$221k
    13 days ago 13d
    209 Regulatory Affairs Employment Type: FTE Location: United States - San Rafael, California Department: Regulatory & Pharmacovigilance… complex regulatory issues of importance to BioMarin. Seasoned regulatory professional with experience in submissions for products…
  • AstraZeneca Pharmaceuticals LP – Redwood City, CA
    3 days ago 3d
    of smaller global function such as CMC, regulatory affairs directors, associate directors and managers, managing health authority… Works collaboratively with the global/regional/local regulatory affairs staff at Acerta and AstraZeneca, to influence developing…
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