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Regulatory Submissions Manager jobs - Cambridge, MA

Viewing 1 - 10 of 1,452 jobs

  • Global Regulatory Lead (anti-PDL1) (63401)

    EMD Serono - Billerica, MA

    and its associated submissions Provide an assessment of regulatory opportunities to potentially enhance the ... strategy accordingly. Ensure top quality across all regulatory submissions. Plan for production of dossier(s)...

    27 days ago from EMD Serono

  • Sr. Regulatory Specialist-Medical Device

    Scientific Search - Marlborough, MA

    for regulatory compliance • Prepares FDA submissions, which may include: 510(k)s, IDEs, IDE Supplements, PMAs, ... industry preparing regulatory submissions for medical devices • Excellent writing skills with ability to write...

    7 days ago from ZipRecruiter

  • Sr. Associate Regulatory Affairs

    Inventiv Health Clinical - Cambridge, MA

    submission activity on several programs Report to head of submissions group, work with Regulatory Development managers ... filings/amendments Qualifications: 1-2 years experiecne in Regulatory Affairs. An understanding of Clinical Operations...

    12 hours ago from Mx Group

  • Manager Global Regulatory Affairs Development

    Takeda Pharmaceuticals North America - Cambridge, MA

    Regulatory Lead with development of global regulatory strategy. •Identifies regulatory requirements and provides ... of regulatory submissions. •Basic working knowledge of drug development process and regulatory requirements.

    30+ days ago from Takeda Pharmaceuticals North America, Inc

  • Senior Global Submission Specialist/Global Submissions Manager

    Takeda Pharmaceuticals North America - Cambridge, MA

    timely, compliant submissions, prepared for global regulatory agencies, in accordance with the worldwide regulatory ... experience working within Regulatory Operations environment. Fluent understanding of submissions publishing...

    30+ days ago from Takeda Pharmaceuticals North America, Inc

  • Sr Manager Site Lead Global Submission Management

    Takeda Pharmaceuticals North America - Cambridge, MA

    submissions are delivered according to the worldwide regulatory submission plan and regional/country ... submissions, prepared for global regulatory agencies, in accordance with the worldwide regulatory submission plan...

    30+ days ago from Takeda Pharmaceuticals North America, Inc

  • Director/Senior Director, Regulatory Affairs

    Merrimack Pharmaceuticals - Cambridge, MA

    The Director/Senior Director of Regulatory Affairs reports to the VP of Regulatory Affairs and is responsible for long- ... regulatory strategies for the earliest possible approval of regulatory submission. Advise and manage the regulatory...

    17 days ago from Mx Group

  • Sr Specialist Regulatory Affairs

    Pharma Search Partners - Boston, MA

    management and cross-functional business partners Conduct regulatory communications with regulatory authorities for ... regulations, guidelines, and regulatory processes Work with Regulatory Operations to ensure e-submissions are complete...

    21 days ago from Career Marketplace, Inc

  • Manager Regulatory Affairs CMC

    Pharma Search Partners - Boston, MA

    MANAGER OF REGULATORY AFFAIRSJob DescriptionThis position is responsible for regulatory execution activities associated ... preclinical and CMC submission documents Work with Regulatory Operations to ensure e-submissions are complete...

    23 days ago from Career Marketplace, Inc

  • CMC, Manager Regulatory Affairs

    Biostaff Solutions - Burlington, MA

    coordinating, writing, and reviewing CMC documents for regulatory submission purposes, conducting regulatory ... documents Work with Regulatory Operations to ensure e-submissions are complete and technically compliant in...

    23 days ago from ZipRecruiter

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