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Regulatory affairs cmc manager Jobs

1,018 Jobs

  • 4.1
    Akebia Therapeutics – Cambridge, MA
    $78k-$120k(Glassdoor est.)
    HOT
    expanding its RegulatoryCMC team to support late phase clinical assets and is searching for a RegulatoryAffairsManager, CMC. This individual… Phase 2) Represent RegulatoryAffairsCMC on Regulatory, CMC, and Supply Chain sub-teams. Provide regulatory guidance and recommendations…
  • 4.4
    Agios Pharmaceuticals – Cambridge, MA
    $117k-$164k(Glassdoor est.)
    5 days ago 5d
    Director of CMCRegulatoryAffairs to join our growing and dynamic team. Reporting to the Director of RegulatoryAffairs, the Associate… Director of CMCRegulatoryAffairs will be the leader in interactions with the Regulatory Authorities as necessary to support CMC activities…
  • 3.3
    Bausch & Lomb – Bridgewater, NJ
    $121k-$182k(Glassdoor est.)
    6 days ago 6d
    Overview The RegulatoryAffairsCMC Associate Director independently manages all regulatoryCMC aspects of Valeant’s Pharmaceuticals… documents on CMC issues. Qualifications  Knowledge of pharmaceutical industry regulatoryaffairsCMC discipline throughout…
  • 2.6
    Valeant Pharmaceuticals – Bridgewater, NJ
    $104k-$157k(Glassdoor est.)
    7 days ago 7d
    hope it will become. The RegulatoryAffairsCMCManager independently manages all regulatoryCMC aspects of Valeant’s Pharmaceuticals… Authority interactions on CMC issues Knowledge of pharmaceutical industry regulatoryaffairsCMC discipline throughout the…
  • 4.1
    Ardelyx – Fremont, CA
    $67k-$109k(Glassdoor est.)
    8 days ago 8d
    RegulatoryAffairsCMCManager Ardelyx® is building an integrated biopharmaceutical company with a gastrointestinal and cardio-renal… the Director of RegulatoryAffairs, this position will be responsible for contributing to proactively managing CMC aspects of one…
  • 3.7
    Seattle Genetics, Inc. – Bothell, WA
    $113k-$170k(Glassdoor est.)
    4 days ago 4d
    the RegulatoryAffairsCMC function on assigned cross-functional project teams Manage interactions with global regulatory authorities… create high quality regulatory submissions that support product development strategy and ensure complete CMC content that meets…
  • 3.1
    Sanofi U.S. – Bridgewater, NJ
    $106k-$167k(Glassdoor est.)
    HOT
    Senior Manager, RegulatoryAffairsCMC Biologics: This position is responsible for providing regulatory Chemistry, Manufacturing… years of RegulatoryAffairs or relevant industry experience Master's degree and at least 3 year of RegulatoryAffairs or relevant…
  • 3.4
    NantWorks – Culver City, CA
    $82k-$159k(Glassdoor est.)
    19 days ago 19d
    the supervision of the RegulatoryAffairs Director, the RegulatoryAffairsManager implements CMCregulatory strategies for assigned… experience with a minimum of 3 years in RegulatoryAffairs. Recent experience in preparing CMC sections of INDs/BLAs is required. Experience…
  • 3.7
    Incyte Corporation – Wilmington, DE
    $105k-$148k(Glassdoor est.)
    NEW
    collaborations in order to communicate regulatoryCMC guidance and strategiesEnsure regulatoryCMC submissions are of high quality consistent… primarily be responsible for leading CMCregulatory strategy developmentexecution and regulatory submission management for early development…
  • 3.1
    Mylan Inc. – Morgantown, WV
    7 days ago 7d
    ensure consistency between the labeling and CMC sections of applications, etc. Manage employees by serving as a mentor and providing… Development, Chemistry and Purchasing. Manage pending ANDAs including ensuring that all regulatory requirements and/or commitments are…
  • 3.9
    Salix Pharmaceuticals – Bridgewater, NJ
    $143k-$200k(Glassdoor est.)
    HOT
    hope it will become. The RegulatoryAffairsCMCManager independently manages all regulatoryCMC aspects of Valeant’s Pharmaceuticals… interactions on CMC issues. Qualifications Knowledge of pharmaceutical industry regulatoryaffairsCMC discipline throughout…
  • 4.4
    PinPoint Solutions – Rockville, MD
    5 days ago 5d
    Search a job and apply in a few steps! ManagerRegulatoryAffairsCMC Rockville, Maryland, United States Ref#: Date… description Manager, RegulatoryAffairs The RegulatoryAffairsManager will support regulatory activities for a Phase…
  • 3.6
    Sanofi – Swiftwater, PA
    5 days ago 5d
    to join our RegulatoryAffairs Department as a CMCManager. Position Summary: The RegulatoryCMC Conformance Manager (RCM) has the… represents RegulatoryAffairs in R&D or IO project teams when product/valence/facility/equipment-related regulatoryCMC expertise…
  • 5.0
    Intersect ENT – Menlo Park, CA
    14 days ago 14d
    and control (CMC) and nonclinical sections of regulatory submissions. Coordinate and prepare regulatory submissions (IND… JOB: Develop and implement global regulatory chemistry, manufacturing and control (CMC) strategies for drug/device combination…
  • 3.2
    Gilead Sciences – Foster City, CA
    26 days ago 26d
    scientific justification is employed in CMCregulatory strategy. Provides strategic regulatory advice as appropriate. Responsible… and thoroughly reviewing regulatory/quality CMC documentation for accuracy and conformance to regulatory/quality requirements. Knowledge…
  • 4.2
    CyberCoders – Menlo Park, CA
    9 days ago 9d
    RegulatoryAffairsManager, CMC Based in beautiful Menlo Park, CA we are a company committed to solving clinical challenges… for our services, we are in need of hiring for a RegulatoryAffairsManager, CMC. If you are interested in joining a leading…
  • 3.9
    Tesaro – United States
    NEW
    Manufacturing and Controls (CMC) Technical Writing function resides organizationally within RegulatoryAffairs and is responsible for… Responsibilities: • Develop and lead the execution of regulatoryCMC submission. • Contribute strategically and scientifically…
  • 3.3
    Vertex Pharmaceuticals – Boston, MA
    $85k-$130k(Glassdoor est.)
    15 days ago 15d
    filing of regulatoryCMC submissions and manage the interactions with Health Authorities for CMC topics. Provide regulatory support… pharmaceutical or biotech industry experience 3+ years of regulatoryaffairsCMC experience (or relevant experience), preferably in Phase…
  • 3.1
    Sanofi U.S. – Swiftwater, PA
    6 days ago 6d
    join our RegulatoryAffairs Department as a CMCManager. Position Summary: The RegulatoryCMC Conformance Manager (RCM) has… represents RegulatoryAffairs in R&D or IO project teams when product/valence/facility/equipment-related regulatoryCMC expertise…
  • 4.4
    Saviance Technology – Westborough, MA
    $45k-$74k(Glassdoor est.)
    12 days ago 12d
    Job Title: Global RegulatoryAffairsCMC Job Location: Westborough, MA Duration: 07+ Months Client: Sanofi Job Id 7545312… to the Associate Director, Global RegulatoryCMC, this position will provide RegulatoryCMC support for the IRiS to SHARE data…
  • 2.6
    Valeant Pharmaceuticals – Bridgewater, NJ
    $113k-$170k(Glassdoor est.)
    11 days ago 11d
    hope it will become. The RegulatoryAffairsCMCManager independently manages all regulatoryCMC aspects of Valeant’s Pharmaceuticals… authority interactions on CMC issues. Knowledge of pharmaceutical industry regulatoryaffairsCMC discipline throughout the…
  • 3.5
    The Fountain Group – Los Angeles, CA
    5 days ago 5d
    The CMCRegulatoryAffairs Network Strategy Implementation Team Lead will provide leadership and be the RegulatoryCMC point… will include formulating and implementing CMCregulatory strategies, lead CMCregulatory activities for assigned projects in line…
  • 2.6
    Valeant Pharmaceuticals – Bridgewater, NJ
    $108k-$163k(Glassdoor est.)
    5 days ago 5d
    The RegulatoryAffairsCMC Associate Director independently manages all regulatoryCMC aspects of Valeant’s Pharmaceuticals… authority guidance documents on CMC issues. Knowledge of pharmaceutical industry regulatoryaffairsCMC discipline throughout the…
  • 3.9
    Salix Pharmaceuticals – Bridgewater, NJ
    $111k-$156k(Glassdoor est.)
    22 days ago 22d
    Overview The RegulatoryAffairsCMC Associate Director independently manages all regulatoryCMC aspects of Valeant’s Pharmaceuticals… documents on CMC issues. Qualifications  Knowledge of pharmaceutical industry regulatoryaffairsCMC discipline throughout…
  • 5.0
    Flexion Therapeutics – Burlington, MA
    EASY APPLY
    NEW
    Join our team as a RegulatoryManager, CMC. In this role, you'll manage, evaluate and complete regulatory projects with a focus… biopharmaceutical industry, with a minimum of 3 years in CMCregulatoryaffairs Experience and knowledge in preparation of INDs and…
  • 2.7
    Agenus – Berkeley, CA
    $121k-$181k(Glassdoor est.)
    4 days ago 4d
    working in regulatoryaffairsCMC including managing post-approval changes for commercial products Proficiency in regulatory (FDA,… Deliver regulatory strategy objectives for global regulatoryCMC, including operational risk management Lead and manage regulatory…
  • 3.3
    Takeda Pharmaceuticals – Cambridge, MA
    $149k-$232k(Glassdoor est.)
    5 days ago 5d
    Join us as a Director / Associate Director, Global RegulatoryAffairs - CMC in our Cambridge office. Here, everyone matters and… Director / Associate Director working on the Global RegulatoryAffairs - CMC team, you will be empowered to xxxx and xxxx, and a…
  • 3.4
    inVentiv Health Clinical – United States
    EASY APPLY
    $51k-$75k(Glassdoor est.)
    5 days ago 5d
    amazing! Duties: Reporting to the Manager/Senior Manager, RegulatoryAffairs, CMC, you'll be responsible for: Coordinating… Job Description: A RegulatoryAffairsCMC Associate is needed for a 6-months contract position at major pharma company in Northern…
  • 4.7
    Information Technology & Healthcare Staffing – San Rafael, CA
    13 days ago 13d
    ITH Staffing is in search of a Senior Manager, RegulatoryAffairsCMC on behalf of our client based out of San Rafael, CA.… Technical Operations organization. Representing the RegulatoryAffairsCMC function on assigned cross-functional project teams.…
  • 3.6
    Integrated Resources – Waltham, MA
    $76k-$117k(Glassdoor est.)
    25 days ago 25d
    Job Title: Manager, RegulatoryAffairsCMC Location: Waltham, MA Duration: 12 Months (Contract To Hire) Job Description… for preparation of CMC submissions for Biologics products. This position will also assist the RegulatoryCMC team with special…
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