# 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: $170K to $195K base salary per year (USD)
- Posted: 2026-10-06
- Apply by: 2026-11-20
- Apply: https://job-boards.greenhouse.io/braveheartbio/jobs/4416990009?utm_source=1752vc&utm_medium=careers
- Page: https://www.1752.vc/careers/jobs/braveheart-senior-manager-regulatory-affairs-2/

## About the role

The Senior Manager, Regulatory Affairs will play a key role in Braveheart Bio’s global regulatory submissions, spanning U.S. IND and NDA activities and ex-U.S. CTA and MAA activities. Reporting to the Vice President of Regulatory Affairs, this individual will prepare and manage submissions to global health authorities and help develop and execute regulatory strategy. The role requires strong knowledge of U.S. Found on 1752vc Careers, the job board for startup and VC roles.

## What they're looking for

- Bachelor’s degree
- Minimum of 7 years of regulatory affairs experience in biotech or pharmaceutical drug development, with a strong focus on U.S., EU, and ex-U.S. clinical trial submissions
- Demonstrated hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, ex-U.S. CTA preparation and coordination, and health authority interactions and response management
- Strong knowledge of U.S. FDA regulations (including 21 CFR Parts 312 and 314), EU regulatory frameworks (including EU CTR 536/2014), EMA guidance and CTA requirements, and applicable ICH guidelines
- Experience managing IND and CTA lifecycle activities (amendments, updates, and maintenance)
- Strong project management and organizational skills, with the ability to work independently, manage multiple priorities, and meet deadlines in a lean, fast-paced environment

Tags: Regulatory

Source: 1752vc Careers, https://www.1752.vc/careers/jobs/braveheart-senior-manager-regulatory-affairs-2/