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Immix Biopharma (Nasdaq: IMMX) · 1 month ago

Director, CMC Regulatory Affairs (CAR T Therapy)

United States

Full-time

Remote

Director/Executive

10+ years exp

Immix Biopharma is a global leader in relapsed/refractory AL Amyloidosis, focused on innovative cell therapies. The Director of CMC Regulatory Affairs is responsible for defining and executing the global CMC regulatory strategy for CAR T cell therapy programs, ensuring compliance and alignment with regulatory expectations throughout the development and approval processes.

Biotechnology

Responsibilities

Develop and own the CMC regulatory strategy for CAR T therapy programs across late-stage clinical development, BLA submission, and post-approval lifecycle

Translate FDA expectations for cell therapy products into actionable CMC and analytical requirements, ensuring alignment with development and manufacturing strategies

Provide regulatory guidance on control strategy, specifications, comparability, stability, validation, and process performance qualification (PPQ)

Lead the planning, authoring, review, and submission of CMC sections (Module 2&3) for BLAs, amendments, supplements, and annual reports

Serve as the primary regulatory reviewer and approver for CMC content, ensuring technical accuracy, consistency, and regulatory defensibility

Oversee responses to FDA information requests, discipline review letters (DRLs), and post-submission questions related to CMC

Act as the CMC regulatory lead in FDA meetings, including pre-BLA, Type B/C meetings, and ad hoc interactions

Prepare briefing packages, talking points, and negotiation strategies related to CMC topics such as process validation, comparability, stability, and analytical methods

Represent the company in regulatory discussions involving novel or complex CAR T manufacturing and analytical approaches

Partner closely with CMC Technical Development, Analytical Development, Manufacturing, Quality, and Supply Chain to ensure regulatory alignment across development activities

Provide regulatory oversight for changes to manufacturing processes, analytical methods, facilities, and suppliers

Guide internal teams on regulatory risk assessments, change control strategy, and global filing impacts

Lead regulatory strategy for filings, post-approval commitments, supplements, comparability protocols, and ongoing CMC lifecycle management

Ensure timely and compliant submission of post-approval changes, annual reports, and stability updates

Monitor evolving global regulatory guidance related to cell and gene therapies and assess impact to existing programs

Provide regulatory oversight for CDMOs, testing laboratories, and other external partners supporting CMC activities

Review and approve vendor-generated CMC documentation intended for regulatory submission

Ensure alignment between contractual deliverables and regulatory expectations

Qualification

CMC regulatory strategyBLA submission experienceFDA interactionsGMP manufacturingAnalytical developmentRegulatory risk managementTechnical depth in cell therapy CMCCross-functional collaborationLeadership skillsCommunication skills

Required

Bachelor's degree required; advanced degree (MS or PhD) in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field preferred

Typically 10+ years of regulatory affairs experience in biotech or pharmaceutical development

Direct, hands-on experience leading CMC regulatory strategy for at least one successful BLA submission, preferably for a CAR T or autologous cell therapy product

Demonstrated experience interacting with FDA on CMC topics, including pre-BLA and late-stage regulatory meetings

Strong background supporting GMP manufacturing and analytical development for cell therapy products

Deep understanding of CMC requirements for CAR T therapies, including autologous manufacturing, vector control, analytical control strategy, and stability

Strong working knowledge of FDA and ICH guidance relevant to CMC and advanced therapies

Experience addressing regulatory considerations for process validation, comparability, specifications, and analytical method validation in cell therapy programs

Proven ability to lead cross-functional teams and influence decision-making at senior leadership levels

Excellent written and verbal communication skills, with demonstrated experience authoring and reviewing complex regulatory documents

Ability to balance regulatory rigor and flexibility with program timelines and business priorities