Director, Regulatory Affairs

Braveheart Bio • San Francisco, CA

2h

About The Position

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. Our lead program is a next-generation myosin inhibitor, licensed from Hengrui Pharma, being developed to transform the treatment of hypertrophic cardiomyopathy (HCM)—the most common inherited cardiac disease.
Currently in Phase 3 clinical development in China for the more common obstructive form of HCM, our candidate has demonstrated a compelling clinical profile that may position it as a best-in-class therapy with meaningful differentiation.
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 Director of Regulatory Affairs will serve as the Global Regulatory Lead and provide regulatory leadership for Braveheart Bio’s Phase 3 hypertrophic cardiomyopathy (HCM) program. Reporting into the Vice President of Regulatory, Safety & Pharmacovigilance, this individual will be responsible for developing and executing global regulatory strategies to support late-stage clinical development, registration readiness, and lifecycle management for our HCM asset. In addition, this role will support the implementation and optimization of regulatory systems and infrastructure as Braveheart continues to scale.

Requirements

• Bachelor’s degree required; advanced degree in life science (MD, PhD, PharmD, or MS) preferred
• A minimum of 10 years of experience in regulatory affairs, including serving as Global Regulatory Lead for investigational products
• Hands-on experience with INDs and/or CTAs and writing regulatory documents
• Experience supporting Phase 3 development and late-stage regulatory activities
• Experience leading regulatory agency interactions and meetings
• Thorough knowledge of US and international regulations as they apply to pharmaceutical drug development
• Demonstrated ability to communicate complex regulatory concepts clearly and effectively across internal and external stakeholders
• Strong strategic skills including demonstrated ability to make complex decisions and defend difficult positions
• Strong track record of strategic leadership, collaboration, and influence in cross-functional settings
• Strong written and verbal communication skills with a collaborative, team-oriented approach
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Nice To Haves

• Experience with marketing applications (e.g., NDAs/BLAs, MAAs) and post-approval supplements and variations is preferred
• Deep familiarity with cardiovascular or rare disease development program is a plus

Responsibilities

• Serve as Global Regulatory Lead for the Phase 3 HCM program, leading the development and execution of regulatory strategies that result in successful registration and post-approval commercialization of our HCM asset
• Provide strategic regulatory input and leadership at program governance forums and core team meetings
• Proactively identify regulatory risks and develop mitigation strategies
• Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness
• Serve as the primary point of contact with FDA and other health authorities as applicable
• Lead regulatory agency meetings and coordinate the preparation of supporting meeting materials
• Ensure the content in regulatory submissions is complete, well-written, and meets all applicable requirements for the program’s development phase
• Partner with and support Clinical, Nonclinical, CMC, and Safety & Pharmacovigilance activities, including the review and submission clinical protocols, IBs, DSURs throughout the product life cycle
• Ensure regulatory deliverables, support clinical timelines, quality standards, and compliance expectations
• Maintain broad and current knowledge of regulatory requirements and guidelines across clinical, nonclinical, submission, and compliance domains
• Support the implementation of additional systems and process improvements as needed

What This Job Offers

• Job Type: Full-time
• Career Level: Director