# (Senior) Manager, Regulatory Affairs at Braveheart

- Company: Braveheart
- What the company does: Advancing treatments to improve outcomes and quality of life for patients with hypertrophic cardiomyopathy and related heart conditions. Backed by a16z.
- Company website: https://www.braveheart.bio
- Type: Startups
- Level: Senior
- Location: San Francisco, CA or Remote or Hybrid
- Work setup: Remote
- Pay: $119K to $190K base salary per year (USD)
- Posted: 2026-06-18
- Apply by: 2026-10-08
- Apply: https://job-boards.greenhouse.io/braveheartbio/jobs/4289748009
- Page: https://www.1752.vc/careers/jobs/braveheart-senior-manager-regulatory-affairs/

## 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

Tags: Regulatory