(Senior) Director, Regulatory Affairs CMC
About The Position
The (Senior) Director, Regulatory Affairs CMC will serve as the Global CMC Regulatory Lead for Braveheart Bio’s HCM program and report to the Vice President of Regulatory Affairs. This hands-on individual contributor will develop and execute the global CMC regulatory strategy to advance the lead asset from Phase 3 through registration, launch supply, and lifecycle management. The role will help build a CMC data package that meets FDA and international expectations, prepare the company for commercial launch, and develop CMC regulatory processes and infrastructure as the company scales. The role provides regulatory CMC leadership across submissions, manufacturing changes, commercial readiness, health-authority interactions, and post-approval activities. The successful candidate will bring thorough knowledge of US and international CMC regulations and ICH guidelines as they apply to pharmaceutical development and manufacturing.
Requirements
- Bachelor's degree required.
- At least 12 years of experience in Regulatory Affairs CMC, including serving as 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 for pharmaceutical development and manufacturing.
- Strong strategic skills, including the 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 and a collaborative, team-oriented approach.
- Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity.
- Flexible, proactive, hands-on mindset with a roll-up-your-sleeves, can-do attitude.
Nice To Haves
- 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.
Responsibilities
- Serve as Global CMC Regulatory Lead for the HCM program and develop and execute 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 (3.2.S and 3.2.P) and Quality Overall Summary content, in partnership with the CMC team.
- Lead 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 support registration and commercial launch readiness.
- 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 and coordinate meeting packages and responses to information requests.
- Support pre-approval inspections in partnership with Quality.
- Identify CMC regulatory risks, develop mitigation strategies, and communicate risks and options to governance forums and core team meetings.
- Ensure CMC content in regulatory submissions is complete, well-written, and appropriate to the program's development phase.
- Manage post-approval CMC changes, supplements, and variations, and provide regulatory assessments of proposed changes.
- Maintain current knowledge of CMC regulatory requirements and guidelines, including ICH Q-series, across US and international markets.
Benefits
- Competitive total rewards package, which may include an annual bonus, equity, and a comprehensive benefits offering.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
