Senior Director, Regulatory Affairs CMC

Braveheart Bio

. Serve as Global CMC Regulatory Lead for the HCM program, developing and executing CMC regulatory strategies supporting registration, launch, and post-approval lifecycle management.

Posted 10/20/2026full-timeSan Francisco • California • United StatesSenior💰 $210,000 - $305,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC regulatory strategy development and execution, with a strong focus on INDs, CTAs, and marketing applications. Proven ability to lead cross-functional teams and manage regulatory interactions with health authorities while ensuring compliance with US and international regulations.

Highest-signal resume keywords

CMC Regulatory Lead ExperienceINDs/CTAs AuthoringRegulatory Strategy DevelopmentKnowledge of ICH GuidelinesExperience with CDMO Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory StrategyINDs/CTAs PreparationProcess Validation/PPQTechnology TransferComparability AssessmentsRegulatory SubmissionsPost-Approval ChangesQuality Overall SummaryManufacturing Technology TransfersSmall-Molecule CMC

Soft Skills

Strategic LeadershipCollaborationInfluenceWritten CommunicationVerbal Communication

Industry Keywords

Regulatory AffairsPharmaceutical DevelopmentFDA InteractionsGlobal CMC RegulationsICH Q-Series Guidelines

About the role

Key responsibilities & impact

Serve as Global CMC Regulatory Lead for the HCM program, developing and executing CMC regulatory strategies supporting registration, launch, and post-approval lifecycle management.
Prepare CMC sections of INDs/CTAs, IMPDs, and marketing applications (NDA/MAA), including Module 3 and Quality Overall Summary content.
Lead CMC regulatory strategy for manufacturing technology transfers, process changes, comparability assessments, and site-to-site bridging.
Provide regulatory input into process validation/PPQ, control strategy, and specifications.
Provide regulatory oversight of CDMO and CTO partners in collaboration with CMC, Quality, and Supply Chain.
Serve as primary CMC contact with FDA and other health authorities; lead agency meetings and coordinate meeting packages and responses.
Support pre-approval inspections with Quality.
Identify CMC regulatory risks, develop mitigation strategies, and communicate risks and options to governance forums and core teams.
Ensure CMC content in regulatory submissions is complete, well-written, and compliant with applicable requirements.
Manage post-approval CMC changes, supplements, and variations.
Maintain current knowledge of CMC regulatory requirements and ICH Q-series guidelines across US and international markets.
Develop and execute global CMC regulatory strategy for BHB-1893 from Phase 3 through registration, launch supply, and lifecycle management.
Help build CMC regulatory processes and infrastructure as Braveheart Bio scales.

Requirements

What you’ll need

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.
Experience leading CMC-related interactions and meetings with FDA and other health authorities.
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.
Federal E-Verify employment authorization verification applies to all new hires.

Benefits

Comp & perks

Competitive total rewards package
Annual bonus eligibility
Equity eligibility
Comprehensive benefits offering