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Regulatory Affairs Director

1 month ago

Rockville, Maryland, United States Proclinical Staffing Full time
Lead Regulatory Affairs for Innovative Biotech Portfolio

Proclinical Staffing is seeking a seasoned Regulatory Affairs professional to spearhead strategic regulatory decisions for a cutting-edge biotech portfolio.

This key role will be responsible for guiding global regulatory pathways, overseeing a growing team, and reporting directly to the c-suite. The ideal candidate will possess a strong track record of leading dynamic teams and navigating complex regulatory environments.

Key Responsibilities:
  • Develop and implement strategic regulatory plans to support the biotech portfolio.
  • Collaborate with cross-functional teams to ensure regulatory compliance and adherence to FDA and global regulations.
  • Lead and mentor a growing team of regulatory professionals.
  • Ensure timely and effective IND/BLA submissions.
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.
  • IND/BLA submission experience is highly desirable.
Compensation:
  • $280,000 to $300,000 per annum.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

We are an equal opportunity employer.