Associate Director/Director, Regulatory Affairs Strategy - Oncology Associate Director/Director, Regulatory Affairs  …

Hamlyn Williams
in Baltimore, MD, United States
Permanent, Full time
Be the first to apply
Competitive
Hamlyn Williams
in Baltimore, MD, United States
Permanent, Full time
Be the first to apply
Competitive
Associate Director/Director, Regulatory Affairs Strategy - Oncology
Job Title: Associate Director/Director, Regulatory Affairs Strategy - Oncology

Reports to: SVP, Head of Regulatory Affairs

Working Arrangement: 100% remote

Our client is a biopharma organization with an exciting pipeline of Oncology indications. Currently with 11 INDs out and an NDA due to be filed this year. This client is looking to build their regulatory affairs division with a strong Associate Director or Director level professional, with experience with global IND and NDA filings. Reporting directly to the SVP Regulatory Affairs, the successful candidate will be expected to be comfortable working in a fast-paced, biotech environment.

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.
  • Responsible for working with development teams to establish and implement global regulatory strategy and plan for assigned projects.
  • Ensure that all internal and external due dates for regulatory milestones are met with quality deliverables.
  • Lead FDA, EMA 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 drugs 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
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