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Manager - Regulatory Affairs

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Lodi, NJ
$110,000 - $155,000
Job Type
Direct Hire
Feb 16, 2018
Job ID
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 regulatory 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.