Director, Global Regulatory Strategy

Hemab Therapeutics; Cambridge (MA); Remote; USD 180,000 - 250,000; Full time

Job summary

Hemab Therapeutics in Cambridge, MA is seeking a Director, Regulatory Affairs to shape and deliver global regulatory strategy for our rare bleeding disorder programs. You will sit close to science and development teams, turning complex data into clear regulatory choices that move programs forward.

This hands-on leadership role owns strategy and agency interactions, anticipates risk early, and helps build the regulatory framework Hemab needs as our pipeline grows, with potential remote East Coast

Qualifications

• Significant regulatory affairs experience with global development programs.
• Experience leading health authority interactions and major regulatory submissions.
• Strong working knowledge of global drug development requirements and interpretation of regulatory guidance.
• Ability to translate scientific, clinical and CMC data into regulatory positions.

Responsibilities

• Develop and own global regulatory strategies for development programs from clinical development through marketing authorization.
• Lead regulatory interactions with health authorities, including meeting strategy and preparation of materials.
• Own the regulatory submissions process, ensuring high-quality deliverables and timely approvals.
• Translate data into clear regulatory positions and practical development choices.
• Identify regulatory risks early and drive mitigation plans with project teams.
• Partner with clinical, CMC, nonclinical, medical and other functions to embed regulatory strategy in development decisions.
• Lead external regulatory vendors with clear ownership of quality and timelines.

Skills

Regulatory affairs

Global development

Health authority interactions

Regulatory strategy

Cross-functional collaboration

Job description

Hemab Therapeutics in Cambridge, MA is seeking a Director, Regulatory Affairs to shape and deliver global regulatory strategy for our rare bleeding disorder programs. You will sit close to science and development teams, turning complex data into clear regulatory choices that move programs forward.

This hands-on leadership role owns strategy and agency interactions, anticipates risk early, and helps build the regulatory framework Hemab needs as our pipeline grows, with potential remote East Coast