Director, Regulatory Affairs — Global Strategy

Hemab Therapeutics; København; Remote; DKK 1,202,000 - 1,669,000; Full time

Job summary

Hemab Therapeutics seeks a Director of Regulatory Affairs to shape global regulatory strategy for rare bleeding disorder programs. This hands-on leadership role will own agency interactions, risk assessment, and strategic direction across development stages.

The candidate will collaborate with clinical, CMC, nonclinical, and medical teams to ensure timely and high-quality submissions and approvals. The position benefits from Hemab's dual hubs in Cambridge, MA and Copenhagen, Denmark, with

Qualifications

• Significant regulatory affairs experience, ideally in small molecules or biologics.
• Experience leading health authority interactions and major regulatory submissions.
• Ability to interpret global regulatory guidance in scientific/clinical data context.
• Proven track record shaping regulatory strategy in development programs.

Responsibilities

• Develop and own global regulatory strategies from clinical development to marketing authorization.
• Lead health authority meetings, strategy, briefing materials, and follow-through.
• Ensure high-quality regulatory submissions and timely approvals with internal/external partners.
• Translate CMC/clinical data into regulatory positions and development choices.
• Identify risks early and drive mitigation plans with cross-functional teams.
• Collaborate across clinical, CMC, nonclinical, medical and other functions to embed regulatory thinking.
• Direct regulatory vendors with clear ownership of quality and timelines.
• Monitor regulatory science changes and translate into action for Hemab's programs.

Skills

Regulatory affairs

Global development

Health authority interactions

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Job description

Hemab Therapeutics seeks a Director of Regulatory Affairs to shape global regulatory strategy for rare bleeding disorder programs. This hands-on leadership role will own agency interactions, risk assessment, and strategic direction across development stages.

The candidate will collaborate with clinical, CMC, nonclinical, and medical teams to ensure timely and high-quality submissions and approvals. The position benefits from Hemab's dual hubs in Cambridge, MA and Copenhagen, Denmark, with