Director, Global Regulatory Strategy

Isbjørn Is; Cambridge, Northern (MA, KY); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Hemab Therapeutics is seeking a Director, Regulatory Affairs to shape global regulatory strategy for rare bleeding disorder programs. You will work closely with science and development teams, translating data into regulatory paths to progress programs.

This hands-on leadership role owns agency interactions, regulatory submissions, and risk mitigation, helping Hemab scale as a clinical-stage company across Cambridge, MA and Copenhagen.

Qualifications

• Significant regulatory affairs experience leading global development programs.
• Experience with health authority interactions and major regulatory submissions for biologics or innovative medicines.
• Ability to interpret regulatory guidance in the context of scientific data.
• Proven track record writing and reviewing regulatory content and leading external partnerships.
• Experience coordinating across functions and geographies to accelerate development.

Responsibilities

• Develop and own global regulatory strategies for one or more development programs.
• Lead regulatory interactions with health authorities and prepare meeting materials.
• Oversee high-quality regulatory submissions and approvals with internal and external partners.
• Translate scientific and CMC data into regulatory positions and development choices.
• Identify regulatory risks early and drive mitigation plans with project teams.
• Partner across clinical, CMC, nonclinical, medical, and other teams to embed regulatory thinking.
• Lead external regulatory vendors with clear ownership of timelines and deliverables.
• Track regulatory changes and translate them into action for Hemab's programs.

Skills

Regulatory strategy

Global development

Health authority interactions

Regulatory submissions

Regulatory writing

Cross-functional collaboration

Job description

Hemab Therapeutics is seeking a Director, Regulatory Affairs to shape global regulatory strategy for rare bleeding disorder programs. You will work closely with science and development teams, translating data into regulatory paths to progress programs.

This hands-on leadership role owns agency interactions, regulatory submissions, and risk mitigation, helping Hemab scale as a clinical-stage company across Cambridge, MA and Copenhagen.