Advancing treatments to improve outcomes and quality of life for patients with hypertrophic cardiomyopathy and related heart conditions. Backed by a16z.
About the role
The (Senior) Manager, Regulatory Affairs will be a key contributor to Braveheart Bio’s global regulatory submissions, with a primary focus on European Union (EU) and ex-U.S. Clinical Trial Application (CTA) planning and execution. Reporting into the Vice President of Regulatory Affairs, this individual will manage the CRO(s) responsible for preparing CTAs, as well as coordinate preparation of cross‑functional deliverables and manage health authority queries and responses.
What they're looking for
- Bachelor’s degree
- Minimum of 5 years of regulatory affairs experience in biotech or pharmaceutical drug development, with a strong focus on EU and ex‑U.S. clinical trial submissions
- Demonstrated hands-on experience with EU CTA submissions in CTIS, CTA preparation and coordination, health authority interactions and response management
- Strong knowledge of EU regulatory frameworks including EU CTR 536/2014, EMA guidance and CTA requirements, and applicable ICH guidelines
- Experience managing CTA lifecycle activities (amendments, updates, and maintenance)
- Strong project management and organizational skills, with ability to work independently, manage multiple priorities, and meet deadlines in a lean, fast-paced environment
More about this role
Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Our lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity.
With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a high-profile and rapidly evolving therapeutic area.
The (Senior) Manager, Regulatory Affairs will be a key contributor to Braveheart Bio’s global regulatory submissions, with a primary focus on European Union (EU) and ex-U.S. Clinical Trial Application (CTA) planning and execution. Reporting into the Vice President of Regulatory Affairs, this individual will manage the CRO(s)...
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