Director, Regulatory Affairs

Damora Therapeutics; Massachusetts; Presencial; USD 180.000 - 250.000; Jornada completa

Descripción de la vacante

Damora Therapeutics in Waltham, MA is seeking a Director of Regulatory Affairs to lead global regulatory strategies for hematologic programs from early development to BLA filings. You will shape submission plans, coordinate with Health Authorities, and guide cross-functional teams through complex regulatory landscapes in a fast-paced startup environment.

This executive role reports to the VP, Regulatory Affairs and requires 8–10 years in regulatory affairs, an advanced degree, and proven

Formación

• Bachelor’s degree and a solid understanding of science and medicine. Advanced degree (MS, PharmD, PhD) a plus.
• 8–10 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.

Responsabilidades

• Generate and implement global regulatory strategies and plans to support development.
• Lead regulatory submissions and health authority interactions to advance programs.
• Provide regulatory guidance to cross-functional teams and identify regulatory risks.
• Represent Regulatory in program teams and ensure alignment with objectives.
• Lead preparation and submission of regulatory documents (INDs, BLAs, CTAs).
• Coordinate with Health Authorities and serve as regulatory contact for assigned programs.
• Promote compliance with regulatory requirements and company policies.
• Stay updated on evolving regulations and improve processes.

Conocimientos

Regulatory leadership

Cross-functional collaboration

Strategic planning

Regulatory strategy

GxP knowledge

Educación

Bachelor's degree or higher

MS/PhD a plus

Descripción del empleo

Damora Therapeutics is an innovative biotechnology company in Waltham, Ma 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.

THE OPPORTUNITY

The Role

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 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 execution of 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.

RESPONSIBILITIES

What You’ll Do

• Generate and contribute to global regulatory strategies, objectives, and plans to support the development of Damora’s assets.
• Lead the execution of regulatory strategies to obtain and maintain investigational applications and support lifecycle management activities.
• Provide 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.
• Represent Regulatory on program and study teams, ensuring alignment of regulatory plans with overall program objectives.
• Lead 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 serving as regulatory contact for assigned programs.
• Partner with internal stakeholders to promote compliance with applicable regulatory requirements and company policies.
• Maintain awareness of evolving regulations and guidance; communicate relevant updates to cross-functional teams.
• Contribute to the development and continuous improvement of regulatory processes and departmental operating procedures.
• Apply strong knowledge of regulatory principles and business objectives to support program-level decision-making and drive effective cross-functional collaboration.

QUALIFICATIONS

You’ll Bring

• Bachelor’s degree and a solid understanding of science and medicine. Advanced degree (MS, PharmD, PhD) a plus.
• 8-10 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.

IMPACT

What Success Looks Like

• Establish and align global regulatory strategies and roadmaps for your assigned program(s) within your first 6–12 months.
• Lead high-quality, on-time regulatory submissions and health authority interactions that move programs from early clinical trials toward registration trials and BLA filings.
• Show up as a trusted cross-functional partner who takes ownership, anticipates regulatory risks, and moves quickly in a startup environment.

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.

A NOTE FOR AGENCIES

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.

Damora Therapeutics is an Equal Opportunity Employer.