CMC Regulatory Director for Cell Therapy

Miltenyi Biotec; Baltimore, Boston, Washington (MD, MA, District of Columbia, NJ); On-site; USD 202,000 - 237,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Job summary

Miltenyi Biomedicine seeks a Director, Regulatory Affairs with a CMC focus to lead regulatory CMC activities for cell therapy programs across the US, Canada, and other regions. The role partners with Bioindustry and Biotec to craft regulatory strategies supporting clinical trials, health authority interactions, and product approvals.

Responsibilities include leading CMC submissions, providing strategic guidance to cross-functional teams, and ensuring readiness for regulatory interactions.

Qualifications

• Bachelor's degree in life sciences; advanced degree preferred.
• 15+ years in biotech/pharma industry with regulatory focus.
• Extensive knowledge of GMPs and CMC documentation for ICH regions.

Responsibilities

• Develop and implement CMC regulatory strategies to support clinical development and lifecycle management.
• Provide strategic regulatory guidance to cross-functional teams to align CMC with regulatory expectations.
• Lead preparation and review of CMC sections for INDs, CTAs, BLAs, and MAAs, including amendments.

Skills

Regulatory strategy development

CMC expertise

IND/CTA/BLA/MAA submissions

Cross-functional leadership

Health authority liaison

Regulatory submissions preparation

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 across the US, Canada, and other regions. The role partners with Bioindustry and Biotec to craft regulatory strategies supporting clinical trials, health authority interactions, and product approvals.

Responsibilities include leading CMC submissions, providing strategic guidance to cross-functional teams, and ensuring readiness for regulatory interactions.