Director of Regulatory Affairs

Associate Director / Director, Regulatory Affairs (Haematology)Location: Boston, MA (Hybrid)Employment Type: Full‑timeOverviewHartmann Young is partnered with a science‑led, venture‑backed biotechnology company advancing a next generation of biologic therapies for serious hematologic diseases with significant unmet need. The company is entering a critical growth phase, with multiple programs demonstrating best‑in‑class potential and anticipated entry into clinical development in 2026.This is a high‑impact opportunity to join a lean, experienced team at a formative stage, where early clinical data will directly inform development strategy, regulatory positioning, and long‑term value creation. The environment is fast‑paced, collaborative, and highly hands‑on, with a clear path from early clinical studies through global registration.The RoleThe Associate Director / Director, Regulatory Affairs will serve as the Global Regulatory Lead (GRL) for assigned program(s), with responsibility for the strategic leadership, development, and execution of globally aligned regulatory strategies. This individual will play a central role in shaping regulatory roadmaps that advance assets from early clinical development into global registration trials and eventual BLA filings.This is a high‑visibility leadership role requiring close partnership with cross‑functional teams, senior leadership, and global health authorities. The position reports to the Vice President of Regulatory Affairs and offers significant ownership and influence over program‑level decision making.Key ResponsibilitiesDevelop, lead, and execute global, science‑based regulatory strategies to support early‑ and late‑stage clinical development programsLead regulatory activities to obtain and maintain INDs, CTAs, and other investigational applications, and support lifecycle management strategiesServe as the Regulatory representative on program and study teams, ensuring alignment between regulatory plans and overall development objectivesLead the preparation, coordination, and submission of key regulatory documents, including INDs, BLAs, CTAs, amendments, and briefing packagesLead and support interactions with global health authorities (e.g., FDA, EMA, PMDA), including meeting strategy, briefing material preparation, and meeting participationProvide regulatory guidance to cross‑functional stakeholders, identifying risks, proposing solutions, and enabling informed program decisionsMaintain awareness of evolving global regulations and regulatory guidance, proactively communicating relevant updates to internal teamsPartner with internal stakeholders to ensure regulatory compliance with applicable global requirements and internal policiesContribute to the development and continuous improvement of regulatory processes, standards, and operating procedures suited to a growing organizationQualificationsBachelor’s degree in a scientific or medical discipline; advanced degree (MS, PharmD, PhD) strongly preferred5–7+ years of Regulatory Affairs experience in biotech or pharmaceutical settingsProven experience leading major regulatory submissions and health authority interactions in the U.S. and ex‑U.S.Demonstrated ability to develop and execute global regulatory strategies across early‑ and late‑stage programsStrong understanding of global regulatory frameworks and the evolving regulatory landscapeAbility to work effectively in a cross‑functional, fast‑paced startup environment, with a high degree of ownership and accountabilityStrong communication, judgment, and stakeholder‑management skillsWhy This OpportunityOpportunity to act as a true Global Regulatory Lead, not a support functionMeaningful ownership at a company entering clinical development with high scientific ambitionDirect exposure to senior leadership and influence on corporate and program strategyHybrid Boston‑based role with flexibility