CMC Regulatory Director—Cell & Gene Therapy

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

Benefits offered by this job

Health, vision, and dental insurance

401(k) plan

Bonuses or commissions eligible

Job summary

Miltenyi Biomedicine seeks a Director, Regulatory Affairs with a CMC focus to lead regulatory CMC activities for cell therapy programs in the US, Canada, and other regions. You will partner with cross-functional teams to develop strategies supporting clinical trials, health authority interactions, and product approvals.

You will provide strategic input on CMC requirements for advanced therapy products and support regulatory submissions throughout the lifecycle, with travel as needed.

Qualifications

• Bachelor's degree in life sciences; advanced degree preferred.
• At least 15 years of experience in biotech/pharmaceutical industry with GMP and CMC knowledge.
• Experience in cell and gene therapy CMC and global regulatory filings; 10% travel.

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 and submission-ready documentation.
• Oversee regulatory input on process changes, comparability assessments, validation activities, and technical justifications to support manufacturing operations and submissions.

Skills

CMC regulatory strategy

Regulatory submissions

GMP knowledge

Cross-functional leadership

Travel 10%

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Miltenyi Biomedicine seeks a Director, Regulatory Affairs with a CMC focus to lead regulatory CMC activities for cell therapy programs in the US, Canada, and other regions. You will partner with cross-functional teams to develop strategies supporting clinical trials, health authority interactions, and product approvals.

You will provide strategic input on CMC requirements for advanced therapy products and support regulatory submissions throughout the lifecycle, with travel as needed.