Capricor Therapeutics, Inc. · 23 hours ago
Manager, CMC Regulatory Affairs
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$120K/yr - $138K/yr
5+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities and ensuring compliance with global regulatory requirements throughout the product lifecycle.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
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
Qualification
Required
Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a closely related field; advanced degree (e.g., MS, PhD, PharmD) 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 Complete Response Letters preferred
Strong project management skills with the ability to manage multiple projects, timelines, and priorities in a fast-paced environment
Excellent communication skills (written and verbal) for effective interaction with internal stakeholders, external partners, and health authorities
Proficiency in regulatory document management systems and tools (e.g., Veeva RIM, document authoring software)
Ability to work independently while collaborating cross-functionally with scientific, manufacturing, and quality teams
Preferred
Advanced degree (e.g., MS, PhD, PharmD)
Experience supporting BLA or similar submissions for regenerative medicine products, with familiarity in addressing CMC deficiencies or Complete Response Letters
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase