The role:The (Senior) Director, Regulatory Affairs CMC will serve as the Global CMC Regulatory Lead and provide regulatory CMC leadership for Braveheart Bio's HCM program. Reporting to the Vice President of Regulatory Affairs, this hands-on individual contributor will develop and execute the global CMC regulatory strategy that carries our lead asset from Phase 3 through registration, launch supply, and lifecycle management. This role will play a central part in building a CMC data package that meets FDA and international expectations and in preparing the company for commercial launch. This role will also help build the CMC regulatory processes and infrastructure as Braveheart continues to scale.
This is an exciting opportunity to join a regulatory function at a pivotal stage in Braveheart's development and make a direct impact on the company's path to global development. The ideal candidate brings thorough knowledge of US and international CMC regulations and ICH guidelines as they apply to pharmaceutical development and manufacturing.
Key responsibilities:- Serve as Global CMC Regulatory Lead for the HCM program, developing and executing CMC regulatory strategies that support successful registration, launch, and post-approval lifecycle management.
- In partnership with the CMC team, prepare the CMC sections of INDs/CTAs, IMPDs, and marketing applications (NDA/MAA), including Module 3 (3.2.S and 3.2.P) and Quality Overall Summary content.
- Lead the CMC regulatory strategy for manufacturing technology transfers and process changes, including comparability assessments and bridging between manufacturing sites.
- Provide regulatory input into process validation/PPQ, control strategy, and specifications to ensure readiness for registration and commercial launch.
- Provide regulatory oversight of CDMO and CTO partners, partnering with CMC, Quality, and Supply Chain on batch documentation, specifications, stability, and change control.
- Serve as the primary CMC point of contact with FDA and other health authorities; lead CMC-related agency meetings (e.g., Type B/C, pre-NDA) and coordinate meeting packages and responses to information requests.
- Support pre-approval inspections in partnership with Quality.
- Proactively identify CMC regulatory risks and develop mitigation strategies; communicate risks and options clearly to governance forums and core team meetings.
- Ensure CMC content in regulatory submissions is complete, well-written, and meets all applicable requirements for the program's development phase.
- Manage post-approval CMC changes, supplements, and variations, and provide regulatory assessments of proposed changes.
- Maintain broad and current knowledge of CMC regulatory requirements and guidelines (including ICH Q-series) across US and international markets.
Required experience & skills:- Bachelor's degree required; advanced degree in a life science, pharmaceutical science, or related field (PhD, PharmD, or MS) preferred.
- A minimum of 12 years in Regulatory Affairs CMC, including serving as the CMC Regulatory Lead for late-stage or commercial products.
- Hands-on experience authoring and reviewing CMC sections for INDs/CTAs and marketing applications (NDAs/MAAs)
- Direct experience supporting commercial readiness, including process validation/PPQ, launch supply, and pre-approval inspection preparation.
- Experience with technology transfer and site-to-site comparability
- Experience overseeing CDMOs from a CMC regulatory perspective.
- Experience with small-molecule drug substance and drug product CMC (oral solid dose experience preferred)
- Experience leading CMC-related interactions and meetings with FDA and other health authorities.
- Experience with post-approval CMC changes, supplements, and variations is preferred.
- Thorough knowledge of US and international CMC regulations and ICH guidelines as they apply to pharmaceutical development and manufacturing.
- 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
Base Salary Range: $210,000 - $305,000
This role is also eligible for a competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.
