Regulatory Affairs
Director, Regulatory Affairs
Resumé
The Director, Regulatory Affairs will shape global regulatory strategy for development programs in rare bleeding disorders, lead health authority interactions and submissions, and partner across functions to manage regulatory risks and frameworks.
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Kort om jobbet
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 grow1 …
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