Job Title: Director, Regulatory Affairs
Location: [Boston, MA or Hybrid/Remote]
Industry: Biotechnology / Biopharma
Type: Full-time
About the Opportunity
I’m working with an innovative biotech company at the forefront of protein engineering and AI-driven therapeutic discovery. They’re on a mission to accelerate the development of next-generation biologics designed to transform patient care. As they advance their pipeline into clinical development, they are building a high-impact regulatory affairs team and need a strategic, experienced leader to join as Director of Regulatory Affairs .
Role Overview
This Director will own global regulatory strategy and execution across multiple preclinical and clinical-stage programs. You’ll be the key regulatory interface with the FDA, EMA, and other global agencies—leading submissions and driving alignment across clinical, CMC, and nonclinical functions. This role reports directly to the Head of Development and offers an exciting chance to shape regulatory strategy at a fast-growing, cutting-edge biotech.
What You’ll Do
What You Bring
Why This Role?
This is a unique opportunity to join a pioneering company pushing the boundaries of biologic drug development. You’ll work with a passionate, multidisciplinary team and have a major impact on regulatory strategy as the company grows and innovates.
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