Job Description

Job Description

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

• Develop and lead regulatory strategies for novel biologic programs from preclinical through clinical phases.
• Manage regulatory submissions, including INDs, CTAs, amendments, and briefing packages.
• Serve as the primary liaison with global regulatory authorities.
• Collaborate cross-functionally with clinical, manufacturing, and nonclinical teams to ensure regulatory compliance and strategic alignment.
• Identify regulatory risks and develop mitigation plans to support program goals.
• Oversee external consultants and vendors as needed to support regulatory activities.
• Contribute regulatory expertise in due diligence, partnerships, and portfolio planning.

What You Bring

• Advanced degree in life sciences, regulatory affairs, or related fields (PhD, PharmD, MS preferred).
• 10+ years in regulatory affairs, ideally in biotech or pharma with biologics experience.
• Proven track record managing regulatory submissions and interactions with FDA, EMA, and other authorities.
• Strong understanding of biologics regulatory requirements and industry best practices.
• Excellent leadership, communication, and project management skills.
• Ability to work effectively in a fast-paced, collaborative, science-driven environment.

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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