Director, Regulatory Affairs

Hemab Therapeutics; København; Hybrid; DKK 1,400,000 - 1,800,000; Full time

Job summary

Hemab Therapeutics is seeking a Director, Regulatory Affairs to shape and deliver global regulatory strategy for development programs in rare bleeding disorders. You will work close to science and development teams to translate data into regulatory decisions and move programs forward.

This hands-on leadership role owns agency interactions, anticipates risk, and builds the regulatory framework Hemab needs as its pipeline grows across Cambridge and Copenhagen.

Qualifications

• Significant regulatory affairs experience (ideally in small molecules) with global development responsibility.
• Experience leading health authority interactions and major regulatory submissions for biologics.
• Strong knowledge of global drug development requirements and ability to interpret guidance in context of data.
• Ability to write and review regulatory content and lead work through others.
• Experience across functions and geographies with influencing decisions.

Responsibilities

• Develop and own global regulatory strategies across programs from development to marketing authorization.
• Lead interactions with health authorities including strategy, briefing materials and follow-through.
• Ensure high-quality regulatory submissions and approvals on agreed timelines.
• Translate scientific, clinical and CMC data into regulatory positions and practical development choices.
• Identify regulatory risks early and drive mitigation plans with project teams.
• Partner across clinical, CMC, nonclinical, medical and other functions for integrated regulatory strategy.
• Lead external regulatory vendors with ownership of quality, timelines and deliverables.
• Track changes in regulatory science and turn them into action where needed.

Skills

Regulatory leadership

Global development

Health authority interactions

Regulatory submissions

Medical writing

Cross-functional collaboration

Biologics experience

Job description

Location: Cambridge, MA, USA (for the right candidate, we can consider remote East Coast) or Copenhagen, Denmark

Reporting to: VP, Regulatory Affairs & Quality

About Hemab

Hemab is building preventative treatments for serious, underserved bleeding disorders. These are therapies designed to work with the body's own biology and stop bleeds before they start, instead of treating them after they happen. Our pipeline spans more than one mechanism and modality, because the patients we're built for don't all fit the same one.

We're a patient-first, science-led, clinical-stage company - we went public via our 2026 IPO, and we're scaling across two homes: Cambridge, MA and Copenhagen, Denmark.

The role

As Director, Regulatory Affairs, you'll shape and deliver global regulatory strategy for Hemab's development programs in rare bleeding disorders. You'll sit close to the science and the development teams, turning complex data and regulatory requirements into clear choices that help our programs move forward.

This is a hands-on leadership role. You'll own regulatory strategy and agency interactions for your programs, anticipate risk early, and help build the regulatory frameworks Hemab needs as our pipeline and company grow.

What you'll do

• Develop and own global regulatory strategies for one or more development programs, from clinical development through marketing authorization.
• Lead regulatory interactions with health authorities, including meeting strategy, briefing materials, preparation and follow-through.
• Take accountability for high-quality regulatory submissions and approvals, working with Hemab colleagues and external partners to deliver against agreed timelines.
• Translate scientific, clinical and CMC data into clear regulatory positions and practical development choices.
• Identify regulatory risks early, assess the available options and drive mitigation plans with project teams.
• Partner across clinical, CMC, nonclinical, medical and other functions so regulatory strategy is built into development decisions rather than added later.
• Lead external regulatory vendors with clear ownership of quality, timelines and deliverables.
• Track changes in regulatory science and requirements that matter to Hemab's programs, and turn them into action where needed.

What you'll bring to Hemab

• Significant regulatory affairs experience (ideally in small molecules) 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 working knowledge of global drug development requirements and the ability to interpret regulatory guidance in the context of scientific and clinical data.
• Evidence that you've anticipated and solved complex regulatory issues, including developing credible options when the path isn't obvious.
• The ability to write and review high-quality regulatory content yourself, while also leading work delivered through colleagues and external partners.
• Experience working across functions and geographies, with the judgement to challenge, influence and reach decisions without slowing the team down.

Nice to have

• Rare disease, hematology or coagulation experience.
• Experience in a clinical-stage biotech where regulatory frameworks and ways of working are still being built.
• Experience with emerging regulatory requirements

What to expect, honestly

Hemab is still building a lot of its own structure. Systems get created as we need them, rather than handed down in advance. In this role, you'll help create some of the regulatory frameworks you work within. We also work across two hubs and multiple time zones, so making those relationships work takes deliberate effort.

You'll fit well here if you take ownership when you hit the first wall, ask for help when you need it, and don't carry much ego about where the answer comes from. For a company our size, how you work matters as much as pedigree. Good structure should help people move faster and trust each other, not create extra layers.

Hemab Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.