Collegium Pharmaceuticals

  • Manager of Regulatory Affairs

    Job Locations US-MA-Canton
    Posted Date 3 months ago(12/18/2017 6:14 PM)
    # of Openings
    Regulatory Affairs & Quality Assurance
  • Overview

    The Company:

    Collegium Pharmaceutical, Inc., a specialty pharmaceutical company focused on the development of innovative treatments for chronic pain, is actively seeking a Manager of Regulatory Affairs to join our rapidly-growing team in Canton, MA. This individual must be ready for the challenges and responsibilities that come from working in a high-energy, fast-paced environment. 



    Key Functions: Maintaining all regulatory files

    • Assembling and collating all material necessary for regulatory filing
    • Submission of all applicable regulatory information to FDA and/or other relevant agencies
    • Maintain primary interface with PharmaKey (agent for electronic submissions to FDA)
    • Maintain and secure all advertising and promotional pieces intended for FDA submission
    • Prepare NDA Annual Report and Periodic Adverse Drug Experience Reports (with vendor)
    • Prepare and maintain all IND submissions to FDA
    • Prepare and maintain all records related to Collegium Compliance Committee
    • Assist new hires and/or interns in understanding the regulatory process and information management systems.


    • BS or MS degree in Pharmaceutical of Life Science with a minimum of 5+ years experience in pharmaceuticals or medical devices
    • Demonstrated knowledge of basic Regulatory systems
    • Strong verbal and written communications skills with the ability to interface with multi-disciplinary teams.


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