Project Lead, Regulatory Affairs

Flexible, United States
Posted 3 years ago

Main Responsibilities:

Lead or participate in preparation of filing for assigned IND, CTA and NDA submissions to FDA or other health authorities. Might manage the interactions with FDA, EMA and other authorities. Provide regulatory support and guidance to cross-functional teams and ensure all applicable global regulatory requirements are considered and appropriately incorporated into clinical and commercial products. Function as RA representative in development project team. RA project lead will work closely with other functions of the company, including quality assurance, clinical development, pharmacovigilance, CMC, clinical operations, and project management. Is responsible for working with development teams to establish and implement global regulatory strategy and plan for assigned projects. Ensures that all internal and external due dates for regulatory milestones are met with quality deliverables. Might lead FDA or other health authority meetings or meeting rehearsals.

Minimum Requirements:

  • BS in Life Sciences or Chemistry required; advanced degree highly preferred
  • 7+ years of pharmaceutical or biotech industry experience
  • 5+ years of hands-on regulatory affairs project lead experience
  • Experience in filing IND and NDA for small molecule innovative drug is essential
  • Experience in establishing global regulatory strategy and plan for early and late development projects
  • Experience with interacting with FDA is essential, and global experience is highly preferred
  • Experience with oncology drug development is highly desirable


Regulatory Affairs

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