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Regulatory Submissions Manager jobs

Viewing 1 - 10 of 10,790 jobs

  • Senior Manager, Global Regulatory Affairs, Oncology (91442)

    EMD Serono - Billerica, MA

    preparation of all regulatory documentation at different Regulatory milestones * Manage of the regulatory agency ... rehearsals and minutes (under supervision of a TA Head or Regulatory Strategist) * Participate to the regulatory...

    27 days ago from EMD Serono

  • Senior Manager, Global Regulatory Affairs CMC (107042)

    EMD Serono - Billerica, MA

    Job Title: Senior Manager, Global Regulatory Affairs CMC EMD Serono is the biopharmaceutical division of Merck KGaA, ... be responsible for regulatory CMC strategies and day-to-day regulatory support of development (pre-market introduction)...

    28 days ago from EMD Serono

  • Lab Supervisor, Regulatory

    Laboratory Corp of America Holdings - Cranford, NJ

    following clinical training; prior supervisory or Regulatory and QA or management experience is a plus. This ... primary responsibility for managing compliance with Regulatory requirements and for ensuring appropriate documentation.



    Gwinnett Medical Center - Lawrenceville, GA

    and experience preparing Institutional Review Board submissions, sponsor communications, and FDA-required forms. ... setting.Demonstrated knowledge and experience with regulatory procedures, HIPAA compliance, and Federal and local...

    19 days ago from Gwinnett Medical Center

  • Regulatory Submission Project Planning Specialist

    Regeneron Pharmaceuticals - Irvington, NY

    MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or ... inspection activities Identifies and communicates regulatory system enhancement needs or technical issues to...

    11 days ago from Biospace

  • Internal Controls over Regulatory Reporting (ICRR) Specialist, Vice President

    Mufg Union Bank - San Francisco, CA

    Job Summary\: The Internal Controls over Regulatory Reporting (ICRR) Specialist reports directly to the ICRR Manager ... of design and operating effectiveness of Regulatory Reporting internal controls and report submissions. Prepare for...

    9 days ago from MUFG Union Bank

  • Manager, Global Regulatory Affairs CMC (107101)

    EMD Serono - Billerica, MA

    preparation of regulatory documentation for submission to regulatory agencies aid in management of change control. ... in research/development/sales * Experience in CMC Regulatory * Good understanding of cGMP and FDA Requirements PERSONAL...

    28 days ago from EMD Serono

  • Sr Director, Regulatory

    Cameron Craig Group - Jersey City, NJ

    tasks: Outline the regulatory strategy,oversee all regulatory operational activities, and function as the key ... related to regulatory interactions (e.g., IND/NDA submissions, regulatory agency meetings, communication,...

    7 days ago from Cameron Craig Group

  • Manager, CMC Regulatory

    Cameron Craig Group - Princeton, NJ

    My client is expanding and seeks a Manager of CMC Regulatory to take on the following tasks: Plan, author, and manage ... Manage and track the progress of planned regulatory submissions to within defined timelines, in collaboration...

    15 hours ago from Cameron Craig Group

  • Regulatory Consultant with Liquent and ectd experience

    IT Trail Blazers Pvt - San Mateo, CA

    regulatory submission process flow (Data Structure of eCTD submissions),NDA/MAA Submissions End to End Understanding of the liquent architecture and integration with documentum Exp in Pharma domain and worked on GxP Validate system Exp...

    9 days ago from Tech Fetch