Director, CMC Regulatory Affairs

Overview

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary Stealth

X exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

• Develop, own, and execute CMC regulatory strategy across the product lifecycle (from development through commercial and post-approval phases) in alignment with global regulatory requirements and Capricor’s overall regulatory and business goals
• Oversee and lead the preparation, authoring, review, final approval, compilation, and submission of CMC sections for major regulatory filings (e.g., IND amendments, BLA modules, supplements, annual reports, MAAs, responses to queries/information requests, and post-approval changes)
• Proactively identify risks related to documentation, content, quality, or timelines for global CMC submissions; collaborate with Manufacturing, Quality, Process Development, MSAT, and other departments to ensure timely delivery of approved, high-quality technical source documents
• Review and approve CMC-related documentation requiring Regulatory Affairs input, including change controls, regulatory impact assessments, technical reports, stability protocols, process validation summaries, comparability protocols, and deviation/investigation reports
• Foster CMC regulatory alignment and phase-appropriate readiness by collaborating with supporting departments (Manufacturing, Quality Assurance, MSAT, Supply Chain, Commercial, etc.) to support development, scale-up, validation, and commercial readiness activities
• Review and approve product labeling with responsibility for CMC-related claims, product descriptions, manufacturing statements, and participate in Advertising & Promotion review committees as needed
• Manage, mentor, and develop regulatory affairs professionals; provide leadership, oversight, accountability, and support to ensure high-performance deliverables and team growth
• Serve as the primary CMC interface with health authorities (primarily FDA for biologics/cell therapies, potentially EMA) for submissions, negotiations, formal meetings (e.g., Type meetings, pre-BLA interactions), and responses to queries or deficiencies (including addressing any CMC-related items from the Deramiocel CRL)
• Monitor global regulatory trends, guidelines, and precedents (e.g., ICH Q updates, FDA guidance on CMC for cellular/gene therapies, advanced therapies) and adapt Capricor’s CMC strategies proactively to maintain compliance and competitive advantage
• Contribute to regulatory risk assessments, gap analyses, contingency planning, and inspection readiness for CMC aspects and manufacturing sites
• Perform such other duties as may be assigned from time to time

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a closely related field; advanced degree (e.g., MS, PhD, Pharm
  
  D) preferred
• 8+ years of experience in regulatory affairs with a strong CMC focus in the pharmaceutical/biotech industry, including significant experience with biologics, cell therapies, or regenerative medicine products; commercial-stage product experience (post-approval lifecycle management) highly preferred
• Proven track record of preparing, authoring, leading, and submitting CMC sections for major regulatory filings (e.g., IND, BLA, NDA, MAA, supplements) to FDA and/or EMA, including successful responses to agency queries, deficiencies, or Complete Response Letters
• In-depth knowledge of global regulatory requirements and guidelines relevant to CMC for biologics and cell therapies (e.g., ICH Q8-Q12, FDA guidance on CMC for cellular therapies, process validation, stability, comparability, potency assays)
• Experience supporting BLA or similar submissions for advanced therapy products, with familiarity in…