Regulatory Affairs Director

3 days ago


Rockville, Maryland, United States Proclinical Staffing Full time
Head of Regulatory Affairs

Proclinical Staffing is seeking a seasoned professional to lead strategic regulatory decisions for an innovative biotech portfolio.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with FDA and global regulations.
  • Lead a growing team of regulatory professionals and provide guidance on regulatory pathways.
  • Collaborate with cross-functional teams to drive business growth and ensure regulatory excellence.
  • Manage IND/BLA submissions and ensure timely regulatory approvals.
  • Stay up-to-date with changing regulatory landscapes and adapt strategies accordingly.

Requirements:

  • 10+ years of experience in Regulatory Affairs, with a focus on biotech or pharma.
  • Oncology/Immuno-Oncology expertise is a must.
  • Strong knowledge of FDA and global regulations, with experience in IND/BLA submissions.

What We Offer:

  • A competitive salary range of $280,000 to $300,000 per annum.

Proclinical Staffing is an equal opportunity employer and a specialist employment agency providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.



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