Director, CMC Regulatory Affairs

Capricor Therapeutics • San Diego, CA

2d • $165,000 - $205,000

About The Position

The Director, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor’s product lifecycle, with primary accountability for Deramiocel’s BLA pathway and advancement of other pipeline candidates from development through potential commercial approval and post-approval maintenance. Reporting to and collaborating closely with the VP of Regulatory Affairs, this role develops and executes CMC regulatory strategy, ensures compliance with global requirements (FDA, ICH, EMA), identifies and mitigates risks, and partners with cross-functional teams (CMC Development, Manufacturing, Quality, MSAT, Supply Chain, and others) to drive successful submissions, health authority interactions, and company objectives in a fast-paced, mission-driven biotech environment.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, Life Sciences, or a closely related field; advanced degree (e.g., MS, PhD, PharmD) 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 addressing CMC issues in late-stage reviews or post-CRL scenarios preferred.
• Strong project management skills with the ability to lead multiple complex projects, manage timelines, resources, and cross-functional dependencies in a dynamic environment.
• Exceptional communication skills (written and verbal) for effective interaction with internal teams, external partners, and health authorities, including authoring clear regulatory documents and presenting strategies.
• Proficiency in regulatory information management systems and tools (e.g., Veeva RIM, document authoring/publishing software).
• Demonstrated leadership abilities, including mentoring and developing team members, fostering collaboration, and driving accountability.
• Ability to work strategically and independently while thriving in a collaborative, fast-paced setting.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director