(Senior) Director, Regulatory Affairs CMC

The role

The (Senior) Director, Regulatory Affairs CMC will serve as the Global CMC Regulatory Lead for the HCM program. This individual contributor will develop and execute global CMC regulatory strategy from Phase 3 through registration, launch supply, and lifecycle management.

What you will do

• Serve as Global CMC Regulatory Lead for the HCM program
• Develop and execute CMC regulatory strategies for registration, launch, and post-approval lifecycle management
• Prepare CMC sections of INDs/CTAs, IMPDs, and marketing applications
• Lead CMC regulatory strategy for manufacturing technology transfers and process changes
• Provide regulatory input into process validation/PPQ, control strategy, and specifications
• Provide regulatory oversight of CDMO and CTO partners
• Serve as the primary CMC point of contact with FDA and other health authorities
• Support pre-approval inspections in partnership with Quality
• Identify CMC regulatory risks and develop mitigation strategies
• Manage post-approval CMC changes, supplements, and variations

Required qualifications

• Bachelor's degree
• Minimum of 12 years in Regulatory Affairs CMC
• Experience 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
• Strong strategic skills
• Strong track record of strategic leadership, collaboration, and influence in cross-functional settings

Nice to have

• Advanced degree in a life science, pharmaceutical science, or related field (PhD, PharmD, or MS)
• Oral solid dose experience
• Experience with post-approval CMC changes, supplements, and variations

Benefits

• Annual bonus
• Equity
• Comprehensive benefits offering

Before you apply

• Braveheart participates in the federal E-Verify program to confirm employment authorization for all new hires

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.