Hiring: Director, Regulatory Affairs Company: Repertoire Immune Medicines Location: Watertown, MA Job Posted Time: 2026-09-15 11:48:19 Target Skills & Keywords : AI, Risk Management About the job Experience: •10+ years of Regulatory Affairs experience in biotechnology or pharmaceutical drug development, with demonstrated progression into regulatory strategy and leadership responsibilities. Required Skills: •This is a hands-on role based in Watertown, MA, requiring in-office presence at least 3 days per week, in a fast-paced, collaborative environment offering the opportunity to directly shape Repertoire’s regulatory strategy and the advancement of innovative therapies for patients. •Serve as the internal Regulatory Lead for Repertoire's clinical-stage oncology programs, developing and executing global regulatory strategy across Phase 1 and Phase 2 development. •Lead regulatory strategy and execution for INDs, CTAs, amendments, and other submissions supporting new and ongoing clinical studies. •Lead health authority interactions with FDA, EU regulatory authorities, and MHRA—including strategy development, briefing materials, meeting preparation, and agency correspondence. •Provide strategic regulatory guidance on early clinical development, including positioning Phase 1 programs for successful Phase 2 development and potential expedited or accelerated pathways (e.g., Fast Track, Breakthrough Therapy). •Partner cross-functionally with Clinical Development, Clinical Operations, CMC, and Quality to embed regulatory strategy into development plans and program decisions. •Advise on clinical protocols, development plans, CMC changes, IND/IMPD content, product stability, and other issues arising during early clinical development. •Proactively identify regulatory risks and opportunities and develop practical, well-vetted strategies to address them. Compensation: •$210,000 - $245,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!