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Regulatory affairs director Jobs

2,803 Jobs

  • 3.3
    Cytokinetics – South San Francisco, CA
    $133k-$206k(Glassdoor est.)
    11 days ago 11d
    President of Regulatory and Compliance, the Director, RegulatoryAffairs will be responsible for leading activities of Regulatory Affairs… Supervises employees, consultants/contractors in RegulatoryAffairs Optimizes employee performance by developing employees…
  • 4.9
    Sage Therapeutics – Cambridge, MA
    $96k-$151k(Glassdoor est.)
    HOT
    issues and mitigate risks. 5+ years of experience in RegulatoryAffairs related to development of pharmaceuticals with a minimum… Serve as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all…
  • 3.3
    Bausch & Lomb – Bridgewater, NJ
    $145k-$306k(Glassdoor est.)
    NEW
    ongoing regulatory training on regulatory issues pertaining to promotion of Company products. Represents regulatoryaffairs in cross… Responsibilities Manages the Regulatory Promotional reviewers for prescription drugs who represent RegulatoryAffairs on the promotional…
  • 3.9
    Salix Pharmaceuticals – Bridgewater, NJ
    $101k-$158k(Glassdoor est.)
    26 days ago 26d
    pharmacy degree required; MS degree a plu. Seven years regulatoryaffairs experience, with a minimum four years direct FDA device… Research and Development, Manufacturing, Legal, Quality, Clinical Affairs, Marketing, US FDA, EU Notified Bodies, Sales, Customer Service…
  • 2.7
    Intarcia Therapeutics, Inc. – Hayward, CA
    $86k-$198k(Glassdoor est.)
    26 days ago 26d
    a key member of our RegulatoryAffairs department, the Executive Director, Regulatory and Technical Affairs is responsible in providing… updating regulatory submissions and for regulatory inspections. In addition, he or she will represent RegulatoryAffairs on various…
  • 3.3
    Bausch & Lomb – Bridgewater, NJ
    $90k-$143k(Glassdoor est.)
    26 days ago 26d
    pharmacy degree required; MS degree a plu. Seven years regulatoryaffairs experience, with a minimum four years direct FDA device… Responsible for regulatory guidance regarding investigational and marketed products (U.S.). Advises Regulatory Management of…
  • 3.7
    Biomérieux – Saint Louis, MO
    $108k-$169k(Glassdoor est.)
    24 days ago 24d
    international career development opportunities. The Director will provide input to regulatory strategies and policies: assist in their development… ensure that regulatory strategies and policies are understood, compliant and successful and that Corporate regulatory processes…
  • 4.7
    Jounce Therapeutics – Cambridge, MA
    $124k-$187k(Glassdoor est.)
    NEW
    improve patients’ lives. The RegulatoryAffairs (RA) Director will serve as the global regulatory lead for assigned programs for… in a scientific or health-related field 10+ years of regulatoryaffairs experience in the biopharmaceutical industry Experience…
  • 3.9
    Blueprint Medicines – Cambridge, MA
    $96k-$151k(Glassdoor est.)
    12 days ago 12d
    immunotherapy. The Associate Director of RegulatoryAffairs will be responsible for developing global regulatory strategies to advance… Blueprint’s oncology portfolio. Reporting to the Director of RegulatoryAffairs, this individual will work with cross-functional…
  • 2.7
    Intarcia Therapeutics, Inc. – Hayward, CA
    $139k-$216k(Glassdoor est.)
    19 days ago 19d
    Opportunity As a key member of our RegulatoryAffairs department, the Director, RegulatoryAffairs (Early Development) will be responsible… Responsibilities: Represent RegulatoryAffairs during development projects to assure early consideration of regulatory and clinical requirements…
  • 2.6
    Valeant Pharmaceuticals – Bridgewater, NJ
    $90k-$142k(Glassdoor est.)
    10 days ago 10d
    pharmacy degree required; MS degree a plu. Seven years regulatoryaffairs experience, with a minimum four years direct FDA device… Research and Development, Manufacturing, Legal, Quality, Clinical Affairs, Marketing, US FDA, EU Notified Bodies, Sales, Customer Service…
  • 3.9
    Salix Pharmaceuticals – Bridgewater, NJ
    $170k-$350k(Glassdoor est.)
    NEW
    ongoing regulatory training on regulatory issues pertaining to promotion of Company products. Represents regulatoryaffairs in cross… Responsibilities Manages the Regulatory Promotional reviewers for prescription drugs who represent RegulatoryAffairs on the promotional…
  • 4.3
    Guardant Health – Redwood City, CA
    $135k-$202k(Glassdoor est.)
    6 days ago 6d
    Description The Director, RegulatoryAffairs will support and provide input into the development of the regulatory strategy. The… IVDs or drug development and regulation affairs requirements · Familiar with regulatory issues and challenges associated with…
  • 2.5
    Glenmark Pharmaceuticals USA – Paramus, NJ
    $99k-$156k(Glassdoor est.)
    20 days ago 20d
    Ownership of day-to-day regulatory responsibilities for assigned projects Participate as RegulatoryAffairs representative on Project… experience in regulatoryaffairs and serving on project teams. Substantial and successful experience with eCTD regulatory submissions…
  • 3.3
    Vertex Pharmaceuticals – Boston, MA
    $78k-$167k(Glassdoor est.)
    NEW
    The Associate Director/Director will be a strategic leader within RegulatoryAffairs, responsible for developing and executing… implementation of the global regulatory development plan for the project Represent Global RegulatoryAffairs (GRA) on cross-functional…
  • 3.2
    Gilead Sciences – Athens, GA
    $79k-$126k(Glassdoor est.)
    26 days ago 26d
    input to the global regulatory product strategy, upon request Share with International RegulatoryAffairs (Int RA)/development… trade groups and regulatoryaffairs professional societies Non Core (but critical) Technical Regulatory work Pharmacovigilance…
  • 3.3
    Bausch & Lomb – Bridgewater, NJ
    $91k-$144k(Glassdoor est.)
    NEW
    become. The Associate Director, RegulatoryAffairs – CMC, independently manages all aspects of regulatory CMC information for Valeant… Provide regulatory support to other Valeant functions during Regulatory Authority inspections Serve as RegulatoryAffairs representative…
  • 3.6
    Regeneron – Tarrytown, NY
    $141k-$219k(Glassdoor est.)
    6 days ago 6d
    Summary: The Senior Director of RegulatoryAffairs will provide leadership on global clinical regulatory activities. Responsibility… interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans…
  • Greenwich Biosciences – Carlsbad, CA
    EASY APPLY
    HOT
    delivery of results. About the role: This Medical Affairs Associate Director will work as head of the Medical Information team,… shortcomings in GW arrangements. Work with the Medical AffairsDirector to review, improve and develop the Medical Information…
  • 2.5
    Alexion Pharmaceuticals – Boston, MA
    $159k-$237k(Glassdoor est.)
    We're Hiring!
    Position Summary The Director of RegulatoryAffairs Chemistry, Manufacturing, and Controls (CMC) will be responsible for providing… development of high quality regulatory submissions Develop strategy for pre-submission meetings with regulatory authorities to reach…
  • 3.1
    Sanofi US – Bridgewater, NJ
    $169k-$262k(Glassdoor est.)
    15 days ago 15d
    TA immunology: Senior Director, Global RegulatoryAffairs The Senior Director will be leading a portion of the immunology franchise… industry experience, with at least 10 years working in regulatoryaffairs (regionally or globally). Delivery of a number of major…
  • 3.1
    Sanofi US – Cambridge, MA
    $144k-$224k(Glassdoor est.)
    15 days ago 15d
    Director, Rare Disease Global Regulatory Team Lead, Global RegulatoryAffairs The Rare Disease Global Regulatory Team Lead (GRTL… Global RegulatoryAffairs (GRA) team based in the US. He/she is responsible for developing long and short-term regulatory strategies…
  • 3.7
    Nektar Therapeutics – San Francisco, CA
    $128k-$199k(Glassdoor est.)
    7 days ago 7d
    related industry is required. Minimum of 8 years hands-on RegulatoryAffairs experience, in either drugs and/or medical devices is… cGXP regulations and provide guidance to project teams on regulatory compliance issues. We are an Equal Opportunity Employer…
  • 3.4
    Alcon – Fort Worth, TX
    $121k-$189k(Glassdoor est.)
    We're Hiring!
    Posting Title DirectorRegulatoryAffairs - OTC Division ALCON Business Unit GLOBAL REGULATORYAFFAIRS AL Country USA… Description •The DirectorRegulatoryAffairs - OTC drives the development and implementation of the Company’s global regulatory strategy…
  • 3.3
    Vertex Pharmaceuticals – Boston, MA
    $138k-$215k(Glassdoor est.)
    5 days ago 5d
    The Director, Global CMC (Chemistry, Manufacturing & Controls) RegulatoryAffairs is responsible for developing and implementing… leads and participates in regulatory agency meetings and interactions and represents the regulatory CMC department with contractors…
  • 2.6
    Elekta – Atlanta, GA
    $116k-$182k(Glassdoor est.)
    8 days ago 8d
    contact us for more details! DirectorRegulatoryAffairs – Americas The DirectorRegulatoryAffairs Americas is a senior management… responsible for the strategic and tactical management of the RegulatoryAffairs Americas group. This role will serve as Elekta’s representative…
  • 4.0
    Alvogen – Pine Brook, NJ
    $70k-$102k(Glassdoor est.)
    HOT
      The Senior RegulatoryAffairs Associate position reports to the Associate Director of RegulatoryAffairs.   RESPONSIBILITIES… goals in timely manner. Represent RegulatoryAffairs in project teams and provide regulatory guidance to R&D and Operation teams…
  • 3.6
    Seattle Genetics, Inc. – Bothell, WA
    $113k-$177k(Glassdoor est.)
    6 days ago 6d
    Reporting to the Executive Director or Executive VP, RegulatoryAffairs, the Associate Director will contribute to the development… submissions to regulatory authorities, both related to IND maintenance and marketing authorization Advise on regulatory requirements…
  • 5.0
    Job Juncture – Cambridge, MA
    We're Hiring!
    high profile trials is expanding and looking for a Director, RegulatoryAffairs for their Global Management Team  Competitive base… office) The Rare Disease Global Regulatory Team Lead (GRTL) is part of the Global RegulatoryAffairs (GRA) team based in the US. He…
  • 3.5
    NRECA – Arlington, VA
    $129k-$194k(Glassdoor est.)
    We're Hiring!
    Protected Veteran Status/Genetic Data Summary RegulatoryAffairsDirector Lead NRECA expert and advocate for all matters… committees. Contributes consistently to the Regulatory Bulletin, the Regulatory Looking Ahead, Week Ahead, Notes, Issues to Watch…
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