Regulatory Affairs Manager

Location: Newton, MA

Summary:

The Regulatory Affairs Manager will be responsible for preparing and maintaining regulatory submission in line with FDA and ICH requirements.

 

Responsibilities:

  • Responsible for the preparation of regulatory submissions in compliance with global requirements. These may include US IND and related amendments, ex-US CTAs and related amendments, and global safety and annual reports.
  • Support meetings with Regulatory Authorities including requesting agency meetings and publishing of associated briefing documents.
  • Work closely with Regulatory Operations to ensure submissions are well planned and meet current standards and submission schedules are adhered to.
  • Manage team reviews of regulatory submissions, authored in-house and/or prepared by CRO’s or consultants.
  • Represent regulatory on relevant project teams.
  • Participate in sub teams depending on the complexity of the project.
  • Maintain up-to-date knowledge of regulatory requirements and communicate in a timely manner any updates that may impact the development programs.

 

Skills & Requirements:

  • BA/BS degree in life sciences, regulatory affairs, or other relevant discipline.
  • 5 years of experience in regulatory affairs with multiple types of US regulatory submissions. Ex-US experience and oncology experience a plus.
  • Knowledge and experience with drafting regulatory documents including forms, cover letters and reports, creation of electronic documentation (bookmarking and hyperlinking) and electronic archiving.
  • Proficient with MS Word, Excel, Power Point and Adobe Professional. Exposure to electronic document management software is desirable.
  • Ability to work effectively with cross-functional departments, RA colleagues, Regulatory Operations, and teams.
  • Strong verbal and written communication skills.