Director, Regulatory Affairs

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

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.