Director, Regulatory Affairs

Director, Regulatory Affairs
Cambridge, MA | On-site

An innovative biotech company based in Cambridge is seeking a Director of Regulatory Affairs to serve as the organization's first regulatory hire. This is a unique opportunity to shape and lead global regulatory strategy at a dynamic, fast-growing company developing next-generation antibody therapeutics targeting novel disease mechanisms.

As Director of Regulatory Affairs, you'll play a hands-on leadership role-overseeing IND/CTA submissions, engaging directly with health authorities, and partnering cross-functionally with internal and external teams to drive critical milestones. This role offers the chance to build the regulatory function from the ground up, with high visibility and impact.

Key Responsibilities

• Develop and execute global regulatory strategies that support preclinical and clinical development programs

• Lead the preparation and submission of key regulatory documents, including INDs, CTAs, and future BLAs/NDAs/MAAs

• Serve as the primary regulatory point of contact with health authorities (FDA, EMA, and others)

• Lead and prepare teams for successful regulatory meetings and interactions

• Collaborate closely with internal stakeholders in R&D, clinical development, and external partners to align regulatory plans with broader development goals

• Proactively identify regulatory risks and develop mitigation strategies

• Monitor evolving regulatory trends and requirements to keep the company at the forefront of global compliance

• Establish internal best practices and build scalable regulatory infrastructure for future growth

Qualifications

• Bachelor's degree (advanced degree preferred)

• 10+ years of regulatory affairs experience within the biotech or pharmaceutical industry

• Deep knowledge of FDA, EMA, and global regulatory frameworks

• Demonstrated success leading IND/CTA and/or BLA/NDA/MAA submissions

• Excellent leadership, communication, and collaboration skills

• A strategic thinker who thrives in a dynamic, high-growth environment

Why Join?
Be part of a mission-driven team pioneering antibody-based treatments for unmet medical needs. This is a rare opportunity to join at a foundational level and help shape the regulatory future of a company poised for major scientific and clinical impact.