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Regulatory Submissions Manager jobs

Viewing 1 - 10 of 243 jobs

  • Manager, Cell Derivation Unit

    American Type Culture Collection (atcc) - Manassas, VA

    as starting material for internal development efforts. The Manager will work cross-functionally within ATCC to ... contract submission, patent applications, regulatory submissions, SOPs, WI and related materials as appropriate.

    14 days ago from BioSpace

  • Global Submissions Specialist Global Submissions Manager

    Deerfield, VA

    from the Principle Global Submissions Manager or line manager, the position will work with the global publishing ... Regulatory Operations environment. Fluent understanding of submissions publishing processes and requirements Broad...

    2 days ago from IvyExec

  • Technical Project Manager, Vaccine Development (6208)

    Path (program For Appropriate Technology In Health) - Seattle, WA

    studies, process development, manufacturing, regulatory submissions, and clinical activities. Help ensure activities ... of product development processes, preferably in biologics, regulatory pathways for biologics (e.g. FDA, EMA), and...

    21 days ago from BioSpace

  • Manager Regulatory Affairs-CMC

    Chesterbrook, PA

    of regulatory impact and supporting their implementation. Regulatory assessment of manufacturing deviations ... sections of regulatory submissions and interactions with regulatory agencies. 15%: Review and approve technical...

    5 days ago from IvyExec

  • Sr. Pharmacovigilance Scientist, Medical Risk Management

    Cubist Pharmaceuticals - Lexington, MA

    databases for safety signals, and drafting of responses to regulatory inquiries on product safety issues. In ... specific safety issues when needed. Submissions and Other Regulatory Filings .Assist in the preparation of safety...

    6 days ago from BioSpace

  • Manager- Regulatory Affairs CMC

    Lexington, MA

    Primary Duties: The Manager CMC Global Regulatory Affairs will direct and manage CMC regulatory strategy of one or more ... sections of regulatory submissions and interactions with regulatory agencies 10%: Collaborate with EU International...

    5 days ago from IvyExec

  • Manager Regulatory Affairs

    Lexington, MA

    deviations Responsibilities: * 10%:Develop CMC regulatory strategy and manage regulatory activities and ... sections of regulatory submissions and interactions with regulatory agencies. * 15%:Review and approve technical...

    22 days ago from IvyExec

  • Senior Manager, Global Regulatory Affairs

    Billerica, MA

    preparation of all regulatory documentation Manage the US regulatory agency interactions, document preparation, ... regulatory affairs Experience in preparation of Regulatory strategies under supervision Experience with...

    23 days ago from IvyExec

  • Associate Director, Regulatory Affairs

    Foster City, CA

    Team, will develop global regulatory strategies, provide regulatory guidance, critically review documents for ... regulatory guidance wherever possible, comments on draft regulatory guidance and communicates changes in regulatory...

    2 days ago from IvyExec

  • Director Regulatory Affairs - CMC

    Lexington, MA

    Manage submissions and interactions with the FDA and other regulatory agencies for CMC issues. Provide regulatory ... sections of regulatory submissions and interactions with regulatory agencies. Review and approve technical...

    5 days ago from IvyExec

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