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  • CMC Regulatory Director: Global Submissions & Strategy

    $176.4k - $228.25k

     ...Neura Market is seeking a Manager/Director of CMC Regulatory Affairs to lead the development and implementation of regulatory strategies for small molecule investigational drugs. This role is critical to facilitating clinical research and ensuring compliance with global... 
    Regulatory
    Remote work

    Neura Market

    New York, NY
    1 day ago

  • Director, Regulatory Affairs CMC

    $190.4k - $285.6k

    Job Description General Summary: The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio... 
    Regulatory
    Full time
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Inc.

    Boston, MA
    2 days ago

  • Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

    $157.2k - $256.6k

     ...As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, support cross... 
    Regulatory
    Work at office
    Remote work
    Worldwide
    Relocation package
    3 days per week

    Initial Therapeutics, Inc.

    Tarrytown, NY
    1 day ago

  • Associate Director, CMC Regulatory Affairs

    $176.4k - $228.25k

     ...Your work will change lives. Including your own. The Impact You’ll Make Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications. Influence... 
    Regulatory
    Local area
    Remote work
    Work from home
    Worldwide

    Neura Market

    New York, NY
    1 day ago

  • Associate Director, CMC Regulatory Affairs (Hematology/Oncology) (Village of Tarrytown)

    $157.2k - $256.6k

     ...As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, support cross... 
    Regulatory
    Full time
    Work at office
    Remote work
    Worldwide
    Relocation package
    3 days per week

    Initial Therapeutics, Inc.

    Tarrytown, NY
    8 hours ago

  • Director, Regulatory CMC

     ...therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer. Overview The Director, Regulatory CMC, is responsible for leading one or more drug development programs, with specific emphasis on global regulatory strategy, regulatory... 
    Regulatory
    Work at office
    Remote work

    Iovance Biotherapeutics, Inc.

    San Carlos, CA
    5 days ago

  • GM, CMC — Lead Next-Gen Life Sciences SaaS (Remote) (Boston)

     ...Veeva Systems, Inc. is seeking a General Manager, CMC to own all aspects of building Veeva’s new CMC business. Reporting to the VP of Regulatory, you will lead a high-performing team of life sciences and technology experts to define strategies, develop products, and scale... 
    Regulatory
    Full time
    Remote work

    Veeva Systems, Inc.

    Boston, MA
    8 hours ago

  • Director, Regulatory Affairs CMC

    $207k - $253k

    ## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime type: Full timeposted on: Posted 3 Days Agojob requisition id...  ...role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations... 
    Regulatory
    Minimum wage
    Full time
    Local area
    Flexible hours

    Madrigalpharma

    Waltham, MA
    5 days ago

  • Sr. Director, Regulatory Affairs - CMC

    $285k - $320k

     ...experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. What You'll Do Lead CMC regulatory strategy and execution across development and post‑approval programs, ensuring high‑quality submissions aligned with global... 
    Regulatory
    Work at office
    Remote work
    Flexible hours

    BridgeBio

    San Francisco, CA
    1 day ago

  • Director, Regulatory Affairs CMC

     ...problem solving and a strong sense of purpose. Position Overview - New York, Houston or Remote We are seeking a Director, Regulatory Affairs CMC, to join the Regulatory Affairs CMC team to support a novel rare disease CNS pipeline. The individual will be part of a team... 
    Regulatory
    Temporary work
    Remote work
    Shift work

    Jimmy Jazz

    Houston, TX
    5 days ago

  • Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product

    $238k - $374k

     ...boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination Product, you will provide strategic leadership and development to global regulatory... 
    Regulatory
    Minimum wage
    Full time
    Temporary work
    Work at office
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    3 days ago

  • Senior Associate, Regulatory CMC

     ...Job Description Job Description DEPARTMENT: Regulatory Affairs LOCATION: Durham, NC, Fully Remote COMPANY: Humacyte Inc (Nasdaq...  ...JOB SUMMARY: We are seeking a Senior Associate, Regulatory CMC with deep expertise in biological and cell therapy products and... 
    Regulatory
    Temporary work
    Local area
    Remote work
    Visa sponsorship

    HUMACYTE GLOBAL INC

    Durham, NC
    10 days ago

  • Associate Director, Regulatory CMC

    $170k - $220k

    Associate Director, Regulatory CMC - Solid Biosciences Charlestown, MA HQ Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular... 
    Regulatory
    Full time
    Temporary work
    Remote work
    Flexible hours

    Solid Biosciences

    Boston, MA
    5 days ago

  • Associate Director, CMC Statistician

    $170k - $198k

     ...Vaxcyte's Global Analytical organization as Associate Director, CMC Statistician. The position will be an integral part of the...  ...collaborate with Process Development, MSAT, Stability, Quality, Regulatory Affairs, Manufacturing, and external partners to develop statistically... 
    Regulatory
    Full time
    Remote work

    Vaxcyte

    Remote
    6 days ago

  • Director, CMC Regulatory Affairs

    $210k - $235k

     ...is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, CMC Regulatory Affairs based in United States. This role offers the opportunity to lead global CMC regulatory strategy for innovative biologic... 
    Regulatory
    Remote job
    Full time

    jobgether

    United States
    22 hours ago

  • Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote)

    $190.8k - $300.3k

     ...Job Description Director/Principal Scientist, Devices and Drug-Device Combinations Regulatory CMC Reporting to the Director of Device Regulatory Affairs for Autoinjector Development Programs, the Director/Principal Scientist in Devices and Drug-Device Combinations... 
    Regulatory
    Full time
    For contractors
    Local area
    Remote work
    Worldwide
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    Rahway, NJ
    1 day ago

  • VP, Regulatory Affairs — Strategic Biotech Reg Leader (Remote) (Charlottesville)

    Contraline seeks a strategic Vice President, Regulatory Affairs to lead global regulatory strategies for its growing pipeline of therapeutic...  .... The role requires collaboration across Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external partners... 
    Regulatory
    Full time
    Remote work

    Contraline

    Charlottesville, VA
    8 hours ago

  • Scientist III - CMC

    $94.9k - $135.6k

    Location Remote Responsibilities Develop regulatory strategy and execution plan for pre‑approval, post‑approval changes and lifecycle management...  ...scientific and regulatory rigor. Provide strategic input on CMC and lifecycle change assessments, including regulatory risk... 
    Regulatory
    Temporary work
    Local area
    Remote work
    Work from home
    Home office
    Flexible hours

    Healthcare Distributors Association

    Dublin, OH
    2 days ago

  • Associate Director, CMC Quality Assurance

    $155k - $201.5k

     ...Associate Director, CMC Quality Assurance At Insmed, every moment and every patient counts — and so does every person who joins...  ...external and internal reports and other documentation required by regulatory agencies, customers or to support the quality assurance... 
    Regulatory
    Contract work
    Remote work
    Flexible hours

    Insmed

    United States
    2 days ago

  • Regulatory Associate

     ...Job Title: Regulatory Associate Requisition : HCR0003161 Client: Merz Job Description: OPEN to remote candidates • Assist...  ...Supplements to Marketing Applications (Labeling, Efficacy, and CMC), Pediatric Study Plans, Orphan Drug Applications, Clinical... 
    Regulatory
    Remote work

    Info Way Solutions

    United States
    18 hours ago

  • Vice President of Regulatory Affairs

     ...As the senior regulatory leader, the full-time remote Vice President of Regulatory Affairs will develop and execute global regulatory strategies...  ...and advancing development programs Strong understanding of clinical development, CMC, and commercialization requirements... 
    Regulatory
    Full time
    Remote work

    Virtual Vocations Inc

    United States
    2 days ago

  • Vice President Regulatory Affairs

     ...The Vice President Regulatory Affairs (RA) is responsible for ensuring that compliance is being upheld for Regulatory Affairs at SAB Biotherapeutics...  ...with Clinical Development/Pharmacovigilance, Manufacturing/CMC, Quality, Medical Affairs and Commercial Readiness teams to... 
    Regulatory
    Interim role
    Work at office
    Home office

    SAB Biotherapeutics, Inc.

    Sioux Falls, SD
    3 days ago

  • Director US Regulatory Global Strategic Labelling

    $220k - $250k

     ...within the United States    SUMMARY:    The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the development...  ...affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and... 
    Regulatory
    Temporary work
    Work at office
    Remote work
    Flexible hours

    Lundbeck

    Deerfield, IL
    3 hours agonew

  • Regulatory Affairs Associate

     ...Parexel is hiring a Senior Regulatory Affairs Associate - CMC Biologics/Vaccines. This role offers remote or office-based work options from Poland. You will craft post-approval CMC submission strategies, assess change controls, review QC/production data for regulatory... 
    Regulatory
    Work at office
    Remote work

    JobsInSAS.com

    Poland, NY
    1 day ago

  • Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)

     ...on  LinkedIn,   Facebook ,  Instagram ,  X and  YouTube. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products... 
    Regulatory
    Full time
    Work at office
    Local area
    Remote work

    AbbVie

    Waltham, MA
    1 day ago

  • Senior Associate, Regulatory Affairs

     ...To support regulatory submissions, the remote Senior Associate, Regulatory Affairs CMC will manage the planning, compilation, quality control, and submission of CMC dossier content for clinical and commercial applications while ensuring compliance with eCTD specifications... 
    Regulatory
    Work at office
    Remote work

    Virtual Vocations Inc

    United States
    3 days ago

  • Senior Regulatory Affairs Specialist

     ...and global registration, the full-time remote Senior Associate Regulatory Affairs will manage regulatory strategies and interactions for...  ...responsibilities: Contribute as a member of the global regulatory CMC product team Interact with authors and subject matter experts... 
    Regulatory
    Full time
    Remote work

    Virtual Vocations Inc

    United States
    1 day ago

  • Director, Regulatory Affairs

     ...Leading the development and implementation of CMC regulatory strategy for small molecule investigational drugs, the full-time remote Director of CMC Regulatory Affairs will manage regulatory submissions, provide strategic advice, and ensure compliance with global regulatory... 
    Regulatory
    Full time
    Remote work
    Worldwide

    Virtual Vocations Inc

    United States
    2 days ago

  • Vice President, Regulatory Affairs

    $200k - $275k

     ...growth as it advances toward late-stage clinical development, regulatory milestones, expanded manufacturing, and future product launch....  ...combination products. Collaborate closely with Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external partners.... 
    Regulatory
    Remote work
    Worldwide

    Contraline Inc.

    Charlottesville, VA
    4 days ago

  • Associate Director, Regulatory Affairs - Biosimilars (US)

    $145.6k - $279.4k

     ...Associate Director, Regulatory Affairs - Biosimilars (US) Sandoz continues to go through an exciting and transformative period as a global...  ...and guidance in partnership with Clinical, Nonclinical, CMC, Analytical Development, Quality, Pharmacovigilance, Medical Affairs... 
    Regulatory
    Work at office
    Remote work
    Relocation package
    Flexible hours

    Sandoz International GmbH

    Princeton, NJ
    1 day ago