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Round Lake

    Regulatory Affairs Specialist - Round Lake, United States - Kelly Science Engineering Technology & Telecom

    Kelly Science Engineering Technology & Telecom
    Kelly Science Engineering Technology & Telecom Round Lake, United States

    1 week ago

    Kelly Science, Engineering, Technology & Telecom background
    Description

    Kelly Science & Clinical is seeking a Regulatory Affairs Ops Specialist near Round Lake, IL.

    Long term contract = ~1 year contract

    Shift: Monday - Friday 1st

    Hybrid - 3 days onsite, 2 remote

    Compensation

    based on experience

    Responsibilities:

    • Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types
    • o Creating timelines for regulatory filings
    • o Providing and maintain templates for authoring.
    • o Overseeing authoring and reviewing of regulatory documents
    • o QC submission documents
    • Contribute to the development of process improvements and procedural documents.
    • Identifying and assessing regulatory risks and risks to timelines.
    • Providing regulatory updates to the project team on different milestones.
    • Working cross functionally with project management, operations, IT and other functions.
    • Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents.
    • Working closely with other members of the Regulatory team and provide support to their projects as needed.
    • Maintaining archival of submissions and health authority communications in Veeva RIM system.
    • Provide regulatory representation on key meetings, including meetings with health agency.

    Qualifications:

    • BA/BS in a scientific field and 2-4 years of proven experience
    • Solid understanding and experience and interpretation of regulatory requirements, with particular emphasis on the US region.
    • Strong organization skills and the ability to track multiple timelines in parallel and manage deadlines.
    • Excellent written and verbal communication and ability to collaborate across functions.
    • Experience with Veeva Vault systems is preferred.
    • Strong team player, self-motivated and able to function independently as well as part of a team
    • Able to work on multiple projects concurrently and adapt to a continuously changing environment.
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