Director, CMC Regulatory Affairs

1w1 week ago

Capricor Therapeutics, Inc.

San Diego, US · Full-time · $225,000 – $300,000

About this role

Capricor Therapeutics (NASDAQ: CAPR) advances transformative cell and exosome-based therapies for rare diseases, led by Deramiocel (CAP-1002) in late-stage development for Duchenne muscular dystrophy. The Director, CMC Regulatory Affairs provides strategic leadership and ownership of CMC regulatory activities across the product lifecycle. Primary accountability focuses on Deramiocel’s BLA pathway and pipeline advancement.

This role develops and executes CMC regulatory strategy aligned with global requirements from FDA, ICH, and EMA. It oversees preparation, authoring, review, and submission of CMC sections for IND amendments, BLA modules, supplements, and responses to health authority queries. Proactively identifies and mitigates risks related to documentation, content, quality, and timelines.

Collaborate closely with cross-functional teams including CMC Development, Manufacturing, Quality, MSAT, and Supply Chain in a fast-paced, mission-driven biotech environment. Serve as primary CMC interface with health authorities for meetings, negotiations, and addressing deficiencies like Deramiocel CRL items. Review and approve CMC-related documentation such as change controls and process validation summaries.

Manage, mentor, and develop regulatory affairs professionals to ensure high-performance deliverables. Monitor global regulatory trends, guidelines, and precedents for cellular therapies to adapt strategies proactively. Contribute to regulatory risk assessments, gap analyses, and inspection readiness for CMC aspects.

Requirements

Expertise in CMC regulatory strategy for biologics and cell therapies across product lifecycle
Experience leading BLA submissions, IND amendments, and MAA filings
In-depth knowledge of FDA, EMA, and ICH requirements for advanced therapies
Proven ability to manage health authority interactions including Type meetings and CRL responses
Strong cross-functional collaboration with CMC Development, Manufacturing, Quality, and MSAT
Familiarity with CMC documentation including stability protocols, process validation, and comparability
Leadership experience mentoring regulatory affairs professionals

Responsibilities

Develop, own, and execute CMC regulatory strategy across the product lifecycle in alignment with global requirements and company goals
Oversee and lead preparation, authoring, review, approval, compilation, and submission of CMC sections for IND amendments, BLA modules, supplements, and responses
Proactively identify risks related to documentation, content, quality, or timelines for global CMC submissions and collaborate with Manufacturing, Quality, and other departments
Review and approve CMC-related documentation including change controls, technical reports, stability protocols, process validation summaries, and deviation reports
Foster CMC regulatory alignment and phase-appropriate readiness by collaborating with Manufacturing, Quality Assurance, MSAT, Supply Chain, and others
Review and approve product labeling for CMC-related claims and participate in Advertising & Promotion review committees
Serve as primary CMC interface with health authorities (FDA, EMA) for submissions, meetings, and responses to deficiencies including Deramiocel CRL
Monitor global regulatory trends, guidelines (ICH Q, FDA CMC for cellular therapies), and adapt strategies for compliance and advantage