Global CMC Regulatory Director, Cell & Gene Therapy

Miltenyi Biotec; Richmond (VA); On-site; USD 250,000 - 272,000; Full time

Benefits offered by this job

Health, vision, and dental insurance

401(k) plan

Job summary

Miltenyi Biotec is seeking a senior regulatory leader to manage the global CMC RA team for our Cell & Gene Therapy portfolio, providing strategic leadership across development, registration and lifecycle management while ensuring global compliance.

You will coach managers, guide submissions (INDs, CTAs, BLAs, MAAs), collaborate with Process Development, Manufacturing, Quality and Clinical Development, monitor regulatory trends, and drive risk mitigation throughout the product lifecycle.

Qualifications

• Master's degree or PhD in a relevant scientific discipline.
• 12+ years hands-on CMC regulatory affairs for CGT.
• Experience supporting global regulatory submissions and interactions with health authorities (FDA/EMA).

Responsibilities

• Lead global CMC RA managers and develop global regulatory strategies for CGT products.
• Review and approve CMC sections for regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, post-approval variations).
• Provide strategic guidance on regulatory requirements related to manufacturing, analytics, specs, comparability, validation and control strategies.
• Assess regulatory impact of manufacturing changes and define global pathways.
• Support interactions with health authorities (FDA, EMA, MHRA).
• Collaborate with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development.
• Monitor regulatory developments and drive regulatory risk assessments and mitigation plans across the lifecycle.

Skills

Leadership

Regulatory strategy

Communication

Project management

Team coaching

Global RA experience

CGT regulatory affairs

Education

Master's degree or PhD in Pharmacy/Biotechnology/Biology/Chemistry

Job description

Miltenyi Biotec is seeking a senior regulatory leader to manage the global CMC RA team for our Cell & Gene Therapy portfolio, providing strategic leadership across development, registration and lifecycle management while ensuring global compliance.

You will coach managers, guide submissions (INDs, CTAs, BLAs, MAAs), collaborate with Process Development, Manufacturing, Quality and Clinical Development, monitor regulatory trends, and drive risk mitigation throughout the product lifecycle.