CMC Regulatory Affairs Director - Cell Therapy

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

Benefits offered by this job

Health insurance

Vision and dental coverage

401(k) plan

Job summary

Miltenyi Biomedicine is seeking a Director of 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 Bioindustry and Biotec to craft regulatory strategies supporting clinical trials, health authority interactions, and product approvals.

The role requires extensive GMP knowledge, leadership of CMC submissions, and collaboration across development and regulatory teams to ensure timely milestones

Qualifications

• Bachelor's degree in life sciences; advanced degree preferred.
• 15+ years in biotech/pharmaceutical regulatory affairs.
• Extensive GMP knowledge for CMC regulatory submissions (ICH regions).
• Experience with cell & gene therapy CMC, late-stage development and launches.
• Experience in global regulatory filings and health authority interactions.

Responsibilities

• Develop and implement CMC regulatory strategies for clinical development and lifecycle management.
• Provide strategic regulatory guidance to cross-functional teams to align with regulatory expectations.
• Lead preparation and review of CMC sections for INDs, CTAs, BLAs, and MAAs.
• Collaborate with process/analytic development, regulatory ops, and external consultants.
• Oversee input on process changes, comparability, validation, and technical justifications.
• Participate in change controls to ensure regulatory compliance.
• Support BLA/MAA CMC preparation and regulatory interactions.
• Represent CMC Regulatory in meetings with global health authorities.

Skills

Regulatory strategy

Cross-functional collaboration

CMC submission experience

GMP knowledge

Regulatory risk assessment

Education

Bachelor's degree in life sciences

Advanced degree in health sciences preferred

Job description

Miltenyi Biomedicine is seeking a Director of 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 Bioindustry and Biotec to craft regulatory strategies supporting clinical trials, health authority interactions, and product approvals.

The role requires extensive GMP knowledge, leadership of CMC submissions, and collaboration across development and regulatory teams to ensure timely milestones