Global CGT CMC Regulatory Leader

Miltenyi Biomedicine; Washington, Baltimore (District of Columbia, MD); On-site; USD 250,000 - 272,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

401(k) plan

Job summary

Miltenyi Biomedicine is seeking a global CMC Regulatory Affairs leader to steer regulatory strategies for CGT products from development through commercialization. You will mentor a team, review submissions, and guide manufacturing, analytical methods, and lifecycle management in collaboration with cross-functional partners.

The role emphasizes leading regulatory strategy, coordinating with FDA/EMA, and ensuring compliance across global programs.

Qualifications

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline; 12+ years demonstrated hands-on expertise in CMC Regulatory Affairs for CGT products is mandatory.
• Extensive experience in Regulatory Affairs within biotechnology and/or pharmaceutical environments.
• Proven experience supporting global regulatory submissions and interactions with health authorities, in particular in Europe and US.

Responsibilities

• Coach mentor and lead global CMC RA manager who will lead global CMC regulatory strategies for CGT products throughout development and commercialization.
• Oversee and develop strategy and review and approve CMC sections for regulatory submissions including INDs, CTAs, BLAs, MAAs, amendments and post-approval variations.
• Oversee and provide strategic guidance on regulatory requirements related to manufacturing processes, analytical methods, specifications, comparability studies, process validation and control strategies.
• Oversee and assess regulatory impact of manufacturing changes and define appropriate regulatory pathways worldwide.
• Support interactions with global health authorities including FDA, EMA, MHRA and other agencies.
• Collaborate closely with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development functions.
• Monitor regulatory developments and industry trends relevant to advanced therapies and translate them into regulatory strategies.
• Drive regulatory risk assessments and mitigation plans across the product lifecycle.

Skills

CMC regulatory leadership

Regulatory strategy

Interaction with health authorities

English fluency

Project management

Leadership

Education

Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline

Job description

Miltenyi Biomedicine is seeking a global CMC Regulatory Affairs leader to steer regulatory strategies for CGT products from development through commercialization. You will mentor a team, review submissions, and guide manufacturing, analytical methods, and lifecycle management in collaboration with cross-functional partners.

The role emphasizes leading regulatory strategy, coordinating with FDA/EMA, and ensuring compliance across global programs.