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About the Role

The (Senior) Director, Regulatory Affairs CMC will serve as the Global CMC Regulatory Lead, providing regulatory CMC leadership for Braveheart Bio’s HCM program. This role will develop and execute the global CMC regulatory strategy from Phase 3 through registration, launch supply, and lifecycle management, building a CMC data package that meets FDA and international expectations and preparing the company for commercial launch. This role will also help build the CMC regulatory processes and infrastructure as Braveheart continues to scale.

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.

Requirements

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

Skills

CMC Regulatory Affairs
IND/CTA authoring and review
NDA/MAA authoring and review
Module 3 authoring
Quality Overall Summary authoring
Manufacturing technology transfer
Process changes
Comparability assessments
Process validation/PPQ
Control strategy
Specifications
CDMO oversight
CTO oversight
Batch documentation
Stability
Change control
FDA interactions
Health authority meetings
Pre-approval inspection support
Risk identification and mitigation
Post-approval CMC changes
Supplements
Variations
ICH guidelines
Strategic decision making
Cross-functional collaboration
Written communication
Verbal communication
Teamwork
Adaptability
Proactiveness
Hands-on approach

Experience Level

12+ years in Regulatory Affairs CMC
Senior

Education Level

Bachelor's degree required
Advanced degree in a life science, pharmaceutical science, or related field (PhD, PharmD, or MS) preferred

Salary/Compensations

$210,000 - $305,000

Benefits

Annual bonus
Equity
Comprehensive benefits offering

About the Company

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.

Equal Opportunity

We are an equal opportunity employer.
We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.
Braveheart participates in the federal E‑Verify program to confirm employment authorization for all new hires.