Associate Director/Director, Regulatory Affairs

Associate Director/Director, Regulatory Affairs

Boston, MA (Hybrid) Full-time

About Us

Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for people with hematologic disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for new disease-modifying treatments. With multiple programs with best-in-class potential on track to enter clinical development in 2026, our goal is to rapidly bring forward optimized treatments with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes.

This is a unique opportunity to join a science-driven company at a formative stage, where early clinical data will directly shape development strategy and drive long-term value. The right candidate will join a team with significant early- and late-stage development experience, with the goal of quickly moving through dose escalation/expansion into pivotal trials.

The Role

The Associate Director/Director, Regulatory Affairs will be the global regulatory lead (GRL), responsible for the strategic leadership, development and execution of science-based, solution-oriented, and globally aligned regulatory strategies for the program(s) under their accountability. This role serves as a regulatory leader, influencing program and regulatory positioning across regions. This is a high-visibility role where you will support the design and lead the execute the regulatory roadmaps that transition assets from early-stage clinical trials into global registration trials and BLA filings.

This role reports to the VP, Regulatory Affairs.

What You’ll Do

• The Associate Director/Director, Regulatory Affairs is responsible for generating and contributing to global regulatory strategies, objectives, and plans to support the development Damora’s assets.
• Leads the execution of regulatory strategies to obtain and maintain investigational applications and support lifecycle management activities.
• Provides regulatory guidance to cross-functional teams based on technical and regulatory knowledge, supporting the development of strategic and tactical plans and identifying regulatory risks associated with product development.
• Represents Regulatory on program and study teams, ensuring alignment of regulatory plans with overall program objectives.
• Leads the preparation, coordination, and submission of regulatory documents (e.g., INDs, BLAs, CTAs, and other relevant submissions).
• Lead and support interactions with Health Authorities, including preparation of briefing materials, meeting leadership, and serve as regulatory contact for assigned programs.
• Partners with internal stakeholders to promote compliance with applicable regulatory requirements and company policies.
• Maintains awareness of evolving regulations and guidance; communicates relevant updates to cross-functional teams.
• Contributes to the development and continuous improvement of regulatory processes and departmental operating procedures.
• Applies strong knowledge of regulatory principles and business objectives to support program-level decision-making and drive effective cross-functional collaboration.

What You’ll Bring

• Bachelor’s degree and a solid understanding of science and medicine. Advanced degree (MS, PharmD, PhD) a plus.
• 5-7 years of regulatory affairs experience in biotech or pharma.
• Experience leading major submissions and health authority interactions in both the US (FDA) and ex-US (EMA, PMDA etc).
• Experience developing and executing regulatory strategies for early and late-stage global programs.
• Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.
• Able to work cross-functionally and in a fast-paced startup environment.

Compensation & Benefits

At Damora Therapeutics, we offer competitive compensation and thoughtfully designed total rewards aligned with industry benchmarks. We believe in rewarding impact and building meaningful ownership for our team.

Agency Policy

We are building our team intentionally and do not accept unsolicited resumes from recruiting or staffing agencies. Agencies should not submit candidates unless directly engaged by Damora’s HR team and operating under a signed agreement. Any resume submitted without prior authorization and a signed agreement will be considered property of Damora Therapeutics, and no referral or placement fees will be paid.