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Regulatory Submissions Manager jobs

Viewing 1 - 10 of 1,343 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...

    18 days ago from EMD Serono

  • Program Lead, Clinical Immunology (98466)

    EMD Serono - Billerica, MA

    team of functional experts focused on securing global regulatory approvals, market access, and optimized ... pre-clinical, process development, manufacturing, clinical, regulatory and marketing processes. * Strong knowledge of...

    9 days ago from EMD Serono

  • Director, Research

    HCA Healthcare - Aventura, FL

    approved research projects. • Provide regulatory, ethical, and methodological advice to individual principal ... CERTIFICATE/LICENSE • Certified IRB Professional (CIP) or Certified IRB Manager (CIM) credential or eligibility and comm...

    24 days ago from HCA Healthcare

  • Regulatory Affairs Associate - CMC

    Scientific Search - Edgewater, NJ

    investigator brochures, safety reports, etc.Develop regulatory strategies for product submissions.Coordinate and ... documentation.Maintain the electronic/paper regulatory archives for all projects, including submissions and...

    17 days ago from ZipRecruiter

  • Regulatory Affairs Manager

    Ajulia Executive Search - Pine Brook, NJ

    The Regulatory Affairs Manager will independently prepare, review and submit high quality regulatory submissions to the ... with regulatory guidelines and applicable federal laws. Submissions include Annual Reports, amendments, ANDA’s and...

    10 days ago from The Ladders

  • Regulatory Affairs Manager - Pharmaceutical

    Rho - South Plainfield, NJ

    for assigned projects. - Prepare, coordinate, manage regulatory submissions (e.g. ANDA, NDA, 510K, CMC , CTAs, ... Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross functional meetings - Interface...

    30+ days ago from The Ladders

  • Technical Writer/ Project Manager

    Glidewell Laboratories - Irvine, CA

    Creates 510K technical submission files and coordinates with Regulatory Affairs on the submission/approval process Suppo ... with Regulatory department to assist with international submissions and writes additional documents that are...

    7 days ago from CareerBuilder

  • Senior Manager, Biostatistics

    Fort Lee, NJ

    detailed analysis plans, clinical study reports, regulatory submissions, etc.), (3) co-authoring manuscripts for ... and broad drug development experience. Experience with regulatory submissions, project and proposal management...

    7 days ago from CareerBuilder

  • Grants Management Coordinator

    Sinclair Community College - Dayton, OH

    experience preferred *Knowledge of standard elements of regulatory compliance for grant-funded projects required *Ability to differentiate roles and responsibilities of project and management staff and other key principals affiliated with...

    30+ days ago from Inside Higher Ed

  • Regulatory Affairs Senior Manager

    Qualified Staffing - Raleigh, NC

    of submissions and communicate status to CompanyProvide US regulatory expertise and regulatory advice on various ... and approve internal change control documentation- Local Regulatory responsible person for the Raleigh siteEnsure...

    22 days ago from ZipRecruiter