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Regulatory Submissions Manager jobs

Viewing 1 - 10 of 1,351 jobs

  • Global Regulatory Affairs Director - US Labeling, Promotion, and Compliance (75761)

    EMD Serono - Rockland, MA

    stakeholders on labeling-relevant Quality Documents and on regulatory enforcement topics including sampling, promotion, ... regulatory authority Develops relationships with other regulatory professionals, associations and authorities for...

    25 days ago from EMD Serono

  • RSC and LEx Administrator/Clinical Regulatory Affairs Associate

    Collabera - Waukegan, IL

    the appropriate roles in RSC and LEx. AddModify Affiliate Regulatory Managers in RSC as personnel change and as new ... regulatory affairs experience preferred. Experience with regulatory submissions in international markets, especially...

    11 days ago from Dice

  • Regulatory Affairs Senior Manager

    Xellia Pharmaceuticals - Raleigh, NC

    communication of and facilitate proper implementation of regulatory strategies on product specific issues ? Follow ... and communicate status to Xellia . ? Provide US regulatory expertise and regulatory advice on various projects.

    9 days ago from Biospace

  • Manager of Regulatory Affairs

    Mattson Resources - Pasadena, CA

    •Prepares and manages all aspects of all ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA ... •Must have extensive experience preparing all types of PMDA/FDA/ISO/CE submissions and documentation...

    30+ days ago from The Ladders

  • Director of Regulatory Affairs - Established Products GCMC

    Pfizer - St Louis, MO

    (CMC) regulatory strategies, completion of CMC regulatory submissions and CMC regulatory conformance for ... within a regulatory affairs function. An experienced regulatory CMC professional or an individual with regulatory...

    9 days ago from Biospace

  • Regulatory/Clinical Affairs and Quality

    Asuragen - Austin, TX

    in order to complete and maintain regulatory filings. • Prepare, file and manage regulatory submissions ... and Technical dossiers for international submissions with regulatory authorities. • Provide regulatory support on...

    18 days ago from Biospace

  • Director US Global Regulatory Affairs Oncology

    Everest Group - Cambridge, MA

    to the Regulatory Sub-team. Work closely with the Global regulatory lead to ensure US regulatory requirements are ... and its associated submissions Provide an assessment of regulatory opportunities to potentially enhance the...

    30+ days ago from The Ladders

  • Senior Director Global Regulatory Affairs Immunology

    Everest Group - Cambridge, MA

    consistent regulatory standards and compliance across regulatory TAs Develop and manage the departmental budget ... industry Proven expertise in managing international regulatory submissions and gaining approvals Proven expertise...

    30+ days ago from The Ladders

  • CMC Regulatory Submissions Manager

    Shire Pharmaceutical - Lexington, MA

    of the line manager, the CMC Regulatory Submissions Manager supports the management and oversight of the CMC ... Products. In addition, the Regulatory Submissions Manager will support the global CMC Regulatory Submissions and...

    4 days ago from Shire Pharmaceutical

  • CMC Regulatory Submissions Specialist

    Teva - West Chester, PA

    context. Teva is currently seeking a CMC Regulatory Submissions Specialist Responsibilities Reports to: ... including technical reports, procedures and global regulatory submissions.reviewing submissions for clarity,...

    4 days ago from

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