Manager - Regulatory Affairs

Cameron Craig Group of Recruiters   •  

Lodi, NJ

Industry: Medical Devices & Diagnostics

  •  

5 - 7 years

Posted 275 days ago

This job is no longer available.

The Manager Regulatory Affairs will be responsible for the following:
 

  • Leading the preparation and filing of regulatory applications (IND, NDA, BLA).
  • Coordinating/meeting with various functional areas in order to identify and obtain information required for regulatory submissions.
  • Developing and/or reviewing regulatory documents (IND, NDA, BLA) in order to ensure that all submissions are of high quality.
  • Leading the preparation of responses to questions from Regulatory Authorities.
  • Developing and maintaining regulatory timelines as well as tracking deliverables to timelines in order to ensure regulatory submission timelines are met.
  • Participating in the development of regulatory strategies
  • Providing strategic input and regulatory advice to the project teams on development programs.
  • Proactively identifying project issues and implementing appropriate regulatory strategies in order to mitigate risks.
  • Interfacing with global regulatory authorities
  • Conducting FDA meetings as necessary to support regu
  • latory filings and applications
  • Preparing and coordinating Briefing Packages for meetings with FDA.


The Manager Regulatory Affairs needs a minimum of 5 years of experience in Regulatory Affairs in the Pharmaceutical industry.

2571235

$110K - $155K