Associate Director / Director, Regulatory Affairs (Haematology)
Location: Boston, MA (Hybrid)
Employment Type: Full‑time
Overview
Hartmann 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 Role
The 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 Responsibilities
- Develop, lead, and execute global, science‑based regulatory strategies to support early‑ and late‑stage clinical development programs
- Lead regulatory activities to obtain and maintain INDs, CTAs, and other investigational applications, and support lifecycle management strategies
- Serve as the Regulatory representative on program and study teams, ensuring alignment between regulatory plans and overall development objectives
- Lead the preparation, coordination, and submission of key regulatory documents, including INDs, BLAs, CTAs, amendments, and briefing packages
- Lead and support interactions with global health authorities (e.g., FDA, EMA, PMDA), including meeting strategy, briefing material preparation, and meeting participation
- Provide regulatory guidance to cross‑functional stakeholders, identifying risks, proposing solutions, and enabling informed program decisions
- Maintain awareness of evolving global regulations and regulatory guidance, proactively communicating relevant updates to internal teams
- Partner with internal stakeholders to ensure regulatory compliance with applicable global requirements and internal policies
- Contribute to the development and continuous improvement of regulatory processes, standards, and operating procedures suited to a growing organization
Qualifications
- Bachelor’s degree in a scientific or medical discipline; advanced degree (MS, PharmD, PhD) strongly preferred
- 5–7+ years of Regulatory Affairs experience in biotech or pharmaceutical settings
- Proven 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 programs
- Strong understanding of global regulatory frameworks and the evolving regulatory landscape
- Ability to work effectively in a cross‑functional, fast‑paced startup environment, with a high degree of ownership and accountability
- Strong communication, judgment, and stakeholder‑management skills
Why This Opportunity
- Opportunity to act as a true Global Regulatory Lead, not a support function
- Meaningful ownership at a company entering clinical development with high scientific ambition
- Direct exposure to senior leadership and influence on corporate and program strategy
- Hybrid Boston‑based role with flexibility
