Regulatory Affairs Manager

2 days ago


Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Inc Full time
Job Summary

Breckenridge Pharmaceutical Inc is seeking a highly skilled Regulatory Affairs Manager to join their team. The successful candidate will be responsible for ensuring compliance with US drug product applications throughout the product lifecycle.

Key Responsibilities:

  • Compile high-quality submissions, including ANDA/NDA modules, amendments, supplements, and annual reports.
  • Maintain awareness of regulatory activities and ensure project deadlines are met.
  • Represent regulatory affairs in project team meetings and provide guidance to team members.
  • Contribute to the preparation of controlled correspondences and meeting packages.
  • Review technical reports and evaluate change controls.
  • Point-of-contact with FDA for exchange of information.
  • Assess and remain current with new and changing guidance/regulations.
  • Train and provide guidance to junior department members.

Requirements:

  • Bachelor's degree in a scientific discipline, such as Chemistry, Biology, or Pharmacy.
  • Minimum 8 years' experience in the Pharmaceutical Industry, with a minimum of 5 years' experience in drug regulatory affairs.
  • Excellent attention to detail and organizational skills.
  • Strong analytical and problem-solving abilities.
  • Effective communication and interpersonal skills.


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