Manager - Regulatory Affairs

Confidential Company  •  Lodi, NJ

5 - 7 years experience  •  Medical Devices & Diagnostics

$110K - $155K
Posted on 02/19/18
Confidential Company
Lodi, NJ
5 - 7 years experience
Medical Devices & Diagnostics
$110K - $155K
Posted on 02/19/18

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.


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