Global Regulatory Strategy Director

Damora Therapeutics; Massachusetts; In loco; USD 180.000 - 250.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Regulatory leadership

Cross-functional collaboration

Strategic planning

Regulatory strategy

GxP knowledge

Formazione

Bachelor's degree or higher

MS/PhD a plus

Descrizione del lavoro

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