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    Sr. Regulatory Operations Specialist - Philadelphia, United States - Piper Companies

    Piper Companies
    Piper Companies Philadelphia, United States

    2 weeks ago

    Default job background
    Description
    Piper Companies is currently seeking a
    Sr. Regulatory Operations Specialistto support a growing and innovative cell and gene therapy company in
    Philadelphia, PA (Hybrid Schedule).

    Responsibilities for the Sr. Regulatory Operations Specialist


    • Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and develop content plans for IND & CTA dossiers.
    • Lead interactions with external publishing teams to compile IND or CTA submissions, including reports and protocol amendments.
    • Support drafting and managing document workflows for major submissions, overseeing interactions with external vendors and internal project teams.
    • Complete administrative sections of IND/CTA submissions.
    • Maintain regulatory systems and processes, including trackers, SharePoint sites, and file-sharing tools for external vendor communication.

    Technical Requirements for the Sr. Regulatory Operations Specialist


    • Bachelor's degree required, with over three years of pharmaceutical/biotech industry experience, including two years in regulatory affairs or operations.
    • Proven track record in supporting regulatory submissions and managing document workflows.
    • Preferred regulatory experience in various regions and technology/indications.
    • Strong ability to manage regulatory workflows in cross-functional teams.
    • Detail-oriented with expertise in FDA submission requirements and familiarity with cell and gene therapy regulatory standards in major markets like the US and EU.

    Compensation & Benefits for the Sr. Regulatory Operations Specialist


    Compensation:
    $45-50/hr.


    • Contract (with strong possibility of extension or possible conversion)

    Comprehensive Benefits package:
    Cigna Medical, Cigna Dental, Vision, 401k w/ ADP

    Keywords:
    Regulatory, IND, CTA, SharePoint, Gene Therapy, Cell Therapy, Biotechnology, FDA, Pharmaceutical, Regulatory Submission

    #LI-JM1 #LI-HYBRID #pando #LI-DNP
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