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Sr. Mgr./Associate Director - Regulatory Affairs

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Location
Monmouth Junction, NJ
Salary
$120,000 - $147,000
Job Type
Direct Hire
Date
Feb 17, 2017
Job ID
2453258
Our client, a major Pharmaceutical Company in the Central NJ  area, is looking for a Sr. Mgr./Associate Director - Regulatory Affairs.
The Sr. Mgr./Associate Director Regulatory Affairs will oversee a variety of projects (IND/NDA/BLA), and they will manage these projects through all phases of development as well as be involved with both post-approval and life-cycle management issues.

The Sr. Mgr./Associate Director Regulatory Affairs will:
  • Develop regulatory strategies
  • Provide regulatory guidance
  • Review documents for submission to FDA
  • Oversee the execution of the US regulatory strategy in line with the project team’s goals.
  • Will work on cross-functional project teams, clinical and commercial teams, and provide strategic regulatory leadership.
The qualified candidate must have strong experience in Regulatory CMC as well as experience with direct interactions with the FDA. 
Experience with Biologics is a plus – but not a requirement.