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Associate Director, Regulatory Affairs Submissions Jobs

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  • 5.0
    Blueprint Medicines – Cambridge, MA
    Est. Salary $113k-$156k
    24 days ago 24d
    Summary: The Associate Director of Regulatory Affairs will be responsibility for developing global regulatory strategies to advance… Reporting to the Director of Regulatory Affairs, this individual will provide strategic input and operational regulatory support to…
  • Greenwich Biosciences – Carlsbad, CA
    EASY APPLY
    Est. Salary $73k-$142k
    25 days ago 25d
    Maintains regulatory systems Escalates any issues that require immediate action to Head of US Regulatory Affairs Other duties… timelines and provides operational guidance and regulatory advice to submission teams Creates or improves existing processes…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $128k-$176k
    2 days ago 2d
    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…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $103k-$166k
    2 days ago 2d
    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…
  • 4.2
    Smith Hanley Associates – Chicago, IL
    5 days ago 5d
    ASSOCIATE DIRECTOR, REGULATORY AFFAIRS FUNCTIONAL INITIATIVES Greator Chicago Area The Associate Director, RA Functional Initiatives… productivity, compliance, quality, and value across the Regulatory Affairs organization. Serves as a trusted advisor to RA sub-function…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $142k-$196k
    2 days ago 2d
    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…
  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $58k-$127k
    1 days ago 14hr
    portfolio of products. Partner with Quality Assurance and Regulatory Affairs to ensure that high quality standards are maintained and… relevant FDA guidelines Experience in writing regulatory documents and submissions Embraces our core values: Put People First,…
  • 2.5
    Medpace – Cincinnati, OH
    Est. Salary $125k-$173k
    9 days ago 9d
    currently seeking a full-time, office-based Associate Director, Regulatory Affairs to join our device team. This position will… project teams to ensure submissions meet regulatory requirements; and Maintain up-to-date knowledge of regulatory requirements.…
  • Flatley Discovery Lab, LLC – Charlestown, MA
    EASY APPLY
    Est. Salary $91k-$172k
    4 days ago 4d
    Discovery Lab is seeking an experienced Director/Associate Director of Regulatory Affairs to support early stage programs within… of hands-on regulatory submission and project team experience. Well-versed in regulatory strategy, and regulatory writing Experience…
  • 3.6
    MSD – West Point, PA
    Est. Salary $64k-$110k
    Today 3hr
    . Under the guidance of a Global Regulatory Affairs - CMC Director, the Associate Director will primarily be responsible for… Associate Director, Regulatory Affairs - CMC-REG002839 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $96k-$228k
    17 days ago 17d
    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…
  • 4.0
    Johnson & Johnson – Jacksonville, FL
    Est. Salary $156k-$215k
    23 days ago 23d
    other brand. The Director, Regulatory Affairs, New Growth will: • Direct the creation of global regulatory product development… Title: Director, Regulatory Affairs, New Growth Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies…
  • 3.6
    PRA Health Sciences – Remote, OR
    Est. Salary $49k-$73k
    1 days ago 16hr
    OverviewThe Regulatory Affairs Associate (RAA) fulfills the role of Local Regulatory Affairs Lead (LRAL) and is responsible for… and amended Regulatory Agency (RA), Central Independent Ethics Committee (IEC), and any other central submissions required in…
  • 2.4
    Agenus – Lexington, MA
    Est. Salary $120k-$166k
    3 days ago 3d
    www.agenusbio.com Agenus is currently looking to hire an Associate Director Regulatory Affairs to join our team. We are looking for someone… submissions, research regulatory issues, interaction with regulatory CRO, optimize regulatory process to improve productivity. This…
  • 2.5
    Medpace – United States
    Est. Salary $126k-$174k
    9 days ago 9d
    Responsibilities Director, Regulatory Affairs Medpace, a full service global clinical research organization (CRO) headquartered… in our Regulatory function in the Boston office. The Director will oversee the process of preparing product submissions to domestic…
  • 3.9
    Salix Pharmaceuticals, Inc. – Bridgewater, NJ
    Est. Salary $117k-$160k
    12 days ago 12d
    Overview: The Regulatory Affairs – CMC Associate Director independently manages all regulatory CMC aspects of Valeant’s Pharmaceuticals… Medical Devices. The Associate Director is responsible for the regulatory CMC strategies of all submissions for products under his…
  • 3.0
    TechUSA – Cranbury, NJ
    1 days ago 1d
    content of regulatory submissions. Coordinate with appropriate personnel and departments to resolve any regulatory questions or… issues. -Act as primary contact/liaison representing Regulatory Affairs with health authorities, internal functional areas, contract…
  • 4.1
    University of Pennsylvania – Philadelphia, PA
    Est. Salary $93k-$129k
    2 days ago 2d
    Medicine (PSOM) is seeking an Associate Director of Regulatory Affairs. This position directs the regulatory aspects of the Gene Therapy… education and experience required. Master’s degree in Regulatory Affairs preferred. RAC preferred. Direct experience with the FDA…
  • Taiho Oncology – Princeton, NJ
    12 days ago 12d
    Ten years previous experience in global regulatory affairs and regulatory submissions for drugs, preferably experience in oncology… CTA submissions. Responsibilities and Duties: Independently directs as well as prepares global regulatory affairs strategies…
  • Axovant (Company Record) – New York, NY
    2 days ago 2d
    external. He / she will report to the Regulatory Affairs VP to support all the submission activities. Project manage NDA compilation… all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards…
  • 4.5
    Achaogen – San Francisco, CA
    Est. Salary $159k-$219k
    12 days ago 12d
    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…
  • 3.2
    Halyard – Alpharetta, GA
    Est. Salary $153k-$209k
    18 days ago 18d
    100 countries. We are currently hiring an Associate Director of Regulatory Affairs in Alpharetta GA Provide Leadership and direction… processes that ensure regulatory compliance are robust and efficient. Position reports to Director of Regulatory Affairs. Provide regulatory…
  • 3.5
    Boehringer Ingelheim – Na Ah Tee, AZ
    Est. Salary $154k-$212k
    3 days ago 3d
    Description: CMC Regulatory Affairs Senior Associate Director who is responsible for global and/or U.S. CMC regulatory support of drugs… biopharmaceuticals. Define CMC regulatory submission strategies; plan, construct and direct the filing of CMC submissions for clinical trial…
  • 3.7
    Alvogen – Pine Brook, NJ
    Est. Salary $66k-$95k
    17 days ago 17d
      The Senior Regulatory Affairs Associate position reports to the Associate Director of Regulatory Affairs.   RESPONSIBILITIES… goals in timely manner. Represent Regulatory Affairs in project teams and provide regulatory guidance to R&D and Operation teams…
  • Axovant Sciences – New York, NY
    Est. Salary $78k-$204k
    3 days ago 3d
    external. He / she will report to the Regulatory Affairs VP to support all the submission activities. Responsibilities… all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards…
  • 3.4
    Acelity – North Richland Hills, TX
    Est. Salary $165k-$226k
    6 days ago 6d
    outside industry associations (e.g., AdvaMed, MDMA, FMDIC, etc) Position Details Job Area: Regulatory Affairs Primary Location… regulations and associated interpretations. Direct, coordinate, review, and may prepare reports for regulatory submissions. Review…
  • 3.9
    Singulex – Alameda, CA
    Est. Salary $112k-$187k
    1 days ago 1d
    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…
  • 3.4
    Real Staffing – South San Francisco, CA
    10 days ago 10d
    individual for the position of Director of Regulatory Affairs. The Director will provide global regulatory strategic and operational… Preferred Experience: At least 10 years' experience in Regulatory Affairs in the Pharmaceutical or Biotechnology industry. Proven…
  • 1.9
    Apex Life Sciences – Philadelphia, PA
    Est. Salary $103k-$169k
    19 days ago 19d
    has an immediate Direct Hire opening for a Associate Director of Regulatory Affairs for a leading client in the Greater Philadelphia… Experience working as a lead in Regulatory Affairs for regulatory strategy for IND submissions Preferred candidates will have…
  • 3.0
    Sanofi U.S. – Westborough, MA
    Est. Salary $116k-$160k
    25 days ago 25d
    from a global perspective and assuring that regulatory submissions are on time and high quality. Additional duties include coordination… Approval Supplements Regulatory strategy development Preparing / Authoring / Reviewing of Submissions â US, EU and Rest of World…
  • 3.9
    Acceleron Pharma Inc. – Cambridge, MA
    Est. Salary $181k-$249k
    4 days ago 4d
    providing regulatory guidance and oversight. You will also contribute to regulatory affairs initiatives aimed at improving internal… global regulatory global submissions (eg, INDs, CTAs, IND safety reports, meeting requests) Establish and manage regulatory timelines…
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