Collegium Pharmaceuticals

Manager of Regulatory Affairs

US-MA-Canton
1 month ago(12/18/2017 6:14 PM)
ID
2017-1213
# of Openings
1
Category
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. 

 

Responsibilities

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.

Qualifications

  • 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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