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    Regulatory Affairs Specialist - Hoboken, United States - Katalyst Healthcares and Life Sciences

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    Description
    Responsibilities
    • Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company.
    • Keeps abreast of regulatory procedures and changes.
    • Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents.
    • ssists in the preparation of international registration dossiers for use in international registration by affiliates.
    • Participates with internal/external teams and builds professional relationships.
    • Identifies and suggests solutions to Regulatory tasks.
    Requirements
    • Bachelor's Degree or equivalent
    • 5 years of related Regulatory Affairs experience.
    • bility to travel based on business needs.


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