Strategic CMC Regulatory Director, Cell Therapy

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

Benefits offered by this job

Health insurance

401(k) plan

Job summary

Miltenyi Biomedicine is seeking 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 Bioindustry and Biotec to develop strategies for clinical trials, health authority interactions, and product approvals.

Responsibilities include authoring CMC sections for INDs, CTAs, BLAs, and MAAs; guiding cross-functional teams; ensuring timely regulatory submissions; and mitigating CMC risks

Qualifications

• 15+ years in biotech/pharmaceutical regulatory affairs.
• Deep experience with CMC documentation for global filings.
• Experience in cell and gene therapy CMC, late-stage development, and launches.

Responsibilities

• Develop and implement CMC regulatory strategies for clinical development and lifecycle management.
• Provide strategic guidance to cross-functional teams to align CMC with regulatory expectations.
• Lead preparation and review of CMC sections for INDs, CTAs, BLAs, MAAs, and responses.
• Collaborate with process/analytical development, regulatory operations, and consultants for timely milestones.
• Oversee change control, validation, and technical justifications for manufacturing operations.
• Represent CMC in meetings with global health authorities and support regulatory submissions.

Skills

CMC regulatory strategy

Regulatory submissions

Cross-functional leadership

Health authority interactions

Risk assessment & mitigation

Education

Bachelor's degree in life sciences

Advanced degree in health sciences

Job description

Miltenyi Biomedicine is seeking 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 Bioindustry and Biotec to develop strategies for clinical trials, health authority interactions, and product approvals.

Responsibilities include authoring CMC sections for INDs, CTAs, BLAs, and MAAs; guiding cross-functional teams; ensuring timely regulatory submissions; and mitigating CMC risks