CMC Regulatory Director – Cell Therapy Strategy

US Diversity Job Search; Gaithersburg (MD); On-site; USD 202,000 - 237,000; Full time

Benefits offered by this job

Health, vision, and dental insurance

401(k) plan

Bonus opportunities

Job summary

Miltenyi Biomedicine seeks a Director of Regulatory Affairs with a CMC focus to lead strategic regulatory activities for cell therapy programs across the US, Canada, and other regions. You will guide cross-functional teams, prepare CMC sections for INDs/CTAs/BLAs/MAAs, and ensure timely regulatory submissions and health authority interactions throughout development and lifecycle.

The ideal candidate brings 15+ years in biotech/pharma with deep CMC, GMP, and global filing experience, and will

Qualifications

• Bachelor's degree in life sciences; advanced degree in health sciences preferred.
• Extensive knowledge of GMPs and key requirements for CMC documentation for regulatory submissions in ICH regions.
• Experience in cell and gene therapy CMC, late-stage development and commercial launch experience is mandatory.
• Experience in reviewing and writing CMC regulatory submission documents for global regulatory filings and related health authority interactions is preferred.

Responsibilities

• Develop and implement CMC regulatory strategies to support clinical development, marketing applications, and post-approval lifecycle management for cell and gene therapy products.
• Provide strategic regulatory guidance to cross-functional teams to align CMC development with regulatory expectations and business objectives.
• Lead the preparation, authorship, and review of CMC sections for INDs, CTAs, BLAs, and MAAs, including amendments and responses to health authority queries.
• Collaborate with process development, analytical development, regulatory operations, and external consultants to ensure timely delivery of CMC milestones, data packages, and submission-ready documentation.
• Oversee and provide regulatory input on process changes, comparability assessments, validation activities, and technical justifications to support manufacturing operations and regulatory submissions.
• Participate in change control evaluations to ensure proposed changes remain within regulatory compliance and align with registered dossiers.
• Support BLA/MAA CMC preparation activities and ensure readiness for regulatory interactions and marketing authorization.
• Represent Regulatory CMC in meetings with global health authorities, including preparation of briefing packages and participation in formal meetings.
• Identify, assess, and communicate CMC regulatory risks across programs and contribute to resolution and mitigation planning.

Skills

CMC regulatory knowledge

GMPs knowledge

Regulatory strategy development

Cross-functional collaboration

IND/CTA/MAA understanding

Education

Bachelor's degree in life sciences

Advanced degree in health sciences

Job description

Miltenyi Biomedicine seeks a Director of Regulatory Affairs with a CMC focus to lead strategic regulatory activities for cell therapy programs across the US, Canada, and other regions. You will guide cross-functional teams, prepare CMC sections for INDs/CTAs/BLAs/MAAs, and ensure timely regulatory submissions and health authority interactions throughout development and lifecycle.

The ideal candidate brings 15+ years in biotech/pharma with deep CMC, GMP, and global filing experience, and will