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Regulatory Affairs Director in Irvine, CA at Lucas Group

Date Posted: 1/14/2019

Job Snapshot

Job Description

We are looking for a proven Pharmaceutical Director of Regulatory Affairs to work with our team to develop a regulatory strategy, getting a product approved.  If you are looking to join a growing company with the pleasure of working from home, continue reading.

Some of your responsibilities include:

  • Lead FDA meetings
  • Post-approval activities
  • Developing strategy for submission
  • Post approval process
  • Prep and maintain Prior Approval Supplements (PAS), New Drug Applications (NDA), Biologics License Applications (BLA)
  • Manage Contract Research Organizations (CMO)
  • Labeling

Travel:  once a month, meeting team occasionally, site visits

Experience Requirements:

  • Over 10 years pharmaceutical regulatory experience
  • Over 5 years drug/biologics experience
  • Bachelor’s in scientific discipline
  • Managing New Drug Application (NDA) and Biological License Application (BLA)
  • Experience with animal derived products
  • Understanding science of peptides and protein products
  • Sterile injectables
  • Electronic Common Technical Document (eCTD)