What are the responsibilities and job description for the Director, Regulatory Affairs position at CSG Talent?
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.
