Global Regulatory Strategy Director – Remote Options

Hemab Therapeutics; Cambridge (MA); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Hemab Therapeutics is seeking a Director, Regulatory Affairs to shape and deliver global regulatory strategy for development programs addressing rare bleeding disorders. The role sits near science and development teams to translate data and regulatory requirements into actionable decisions.

This hands-on leadership position owns regulatory strategy, agency interactions, risk mitigation, and builds regulatory frameworks as the pipeline grows across two hubs and time zones.

Qualifications

• Significant regulatory affairs experience with direct responsibility for global development programs and regulatory strategy.
• Experience leading health authority interactions and major regulatory submissions for biologic and/or other innovative medicines.
• Strong ability to interpret regulatory guidance in context of scientific data and to write high-quality regulatory content.

Responsibilities

• Develop and own global regulatory strategies for development programs through marketing authorization.
• Lead regulatory interactions with health authorities, including meeting strategy and briefing materials.
• Ensure high-quality regulatory submissions and approvals within timelines.

Skills

Regulatory affairs

Global development

Health authority interactions

Regulatory submissions

Cross-functional leadership

Job description

Hemab Therapeutics is seeking a Director, Regulatory Affairs to shape and deliver global regulatory strategy for development programs addressing rare bleeding disorders. The role sits near science and development teams to translate data and regulatory requirements into actionable decisions.

This hands-on leadership position owns regulatory strategy, agency interactions, risk mitigation, and builds regulatory frameworks as the pipeline grows across two hubs and time zones.