Manager, 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.

The Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor’s product lifecycle, with a primary focus on supporting the BLA pathway for Deramiocel and advancing other pipeline candidates from development through potential commercial approval and post-approval maintenance. This role supports the development and implementation of CMC regulatory strategy, ensures compliance with global regulatory requirements (including FDA, ICH, and EMA guidelines), and partners closely with cross-functional teams (e.g., CMC Development, Manufacturing, Quality Assurance, Clinical, and Regulatory) to enable timely submissions, successful interactions with health authorities, and achievement of company objectives in a dynamic biotech environment.

• Support the development and execution of CMC regulatory strategy across the product lifecycle (development through commercial and post-approval) to ensure regulatory compliance and alignment with global requirements.
• Lead the preparation, authoring, review, compilation, and submission of CMC sections for regulatory filings (e.g., IND amendments, BLA modules, supplements, annual reports, responses to information requests, and post-approval changes).
• Collaborate with internal CMC, Manufacturing, Quality Assurance, Process Development, and other supporting departments to ensure timely generation, review, and approval of source documents required for regulatory submissions (e.g., stability data, comparability protocols, process validation reports).
• Review and approve CMC-related documentation requiring Regulatory Affairs input, including change controls, regulatory impact assessments, technical reports, stability protocols, validation master plans, and deviation investigations.
• Interface directly with health authorities (primarily FDA, potentially EMA) for CMC-related submissions, negotiations, meetings (e.g., Type meetings, pre-submission interactions), and responses to queries or deficiencies (including addressing any outstanding CMC items from prior BLA feedback).
• Monitor evolving global regulatory changes, guidelines, and precedents (e.g., ICH updates, FDA biologics guidance for cell therapies) and assess impacts on Capricor projects, providing proactive recommendations to leadership.
• Contribute to regulatory risk assessments, gap analyses, and contingency planning for CMC aspects of submissions and lifecycle management.
• Support inspection readiness activities related to CMC documentation 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.
• 5+ years of experience in regulatory affairs with a strong CMC focus in the pharmaceutical/biotech industry, preferably for biologics, cell therapies, or advanced therapy medicinal products (ATMPs).
• Demonstrated experience preparing, authoring, and submitting CMC sections for major regulatory filings (e.g., IND, BLA, NDA, MAA, supplements) to FDA and/or EMA, including responses to agency queries.
• Solid knowledge of global regulatory requirements and guidelines relevant to CMC for biologics/cell therapies (e.g., ICH Q8-Q12, FDA guidance on CMC for cellular therapies, comparability, process validation, stability).
• Experience supporting BLA or similar submissions for regenerative medicine products, with familiarity in addressing CMC deficiencies or…