Regulatory Affairs Strategist

7 days ago


Philadelphia, Pennsylvania, United States Proclinical Staffing Full time

**Job Description:**

We are seeking a Senior Level Regulatory Consultant to join our team in Philadelphia.

This role will provide strategic input and day-to-day guidance for assigned projects within the oncology and medical devices sector. You will work closely with cross-functional teams and report directly to the Head of Medical Affairs and Clinical Development.

  • **Responsibilities:
  • Set the regulatory strategy for the organization and provide regulatory guidance to cross-functional teams and functional areas for project(s) assigned, i.e. from product/indication nomination through early to late-stage clinical development
  • Plan and manage preparation and filing of regulatory submissions (clinical, nonclinical, CMC) for assigned product(s)/program(s) including BLA submissions as well as expedited programs such as Fast Track, Breakthrough, Orphan Drug Designation

**Requirements and Qualifications:**

  • Minimum of BA/BS + 8 years; MS + 6 years; or PhD/PharmD + 4 years of experience in regulatory affairs within the biotech or pharmaceutical industry, including direct experience interacting with the US FDA; experience with CBER preferred
  • Regulatory or scientific experience with anti-cancer immunotherapy

**Estimated Salary:** $120,000 - $150,000 per year



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