Global CMC Regulatory Director, Cell & Gene Therapy

US Diversity Job Search; Philadelphia (Philadelphia County); On-site; USD 250,000 - 272,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

401(k) plan

Job summary

Miltenyi Biomedicine Inc. seeks a global CMC Regulatory Affairs leader to guide regulatory strategy for our Cell & Gene Therapy portfolio.

You will manage development, submission and lifecycle activities, collaborating with FDA, EMA and other authorities to ensure compliant, timely delivery. You will oversee CMC sections for INDs, CTAs, BLAs, MAAs and post-approval changes, while mentoring a team of global CMC RA managers and coordinating with Process Development, Manufacturing, Quality and

Qualifications

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline.
• +12 years hands-on expertise in CMC Regulatory Affairs for CGT products.
• Experience supporting global regulatory submissions and health authority interactions (EU/US).
• Deep understanding of biologics, ATMPs, and global regulatory frameworks.
• Excellent communication, leadership and project management skills.
• Fluent English written and verbal communication.

Responsibilities

• Lead global CMC RA team and provide regulatory leadership across development, registration and lifecycle management for CGT products.
• Oversee CMC sections for regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, post-approval variations).
• Provide strategic guidance on manufacturing processes, analytics, specs, comparability, process validation and control strategies.
• Assess regulatory impact of manufacturing changes and define global regulatory pathways.
• Support interactions with FDA, EMA, MHRA and other authorities in collaboration with local RA reps.
• Collaborate with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development.
• Monitor regulatory developments and translate them into strategies; drive risk assessments.

Job description

Miltenyi Biomedicine Inc. seeks a global CMC Regulatory Affairs leader to guide regulatory strategy for our Cell & Gene Therapy portfolio.

You will manage development, submission and lifecycle activities, collaborating with FDA, EMA and other authorities to ensure compliant, timely delivery. You will oversee CMC sections for INDs, CTAs, BLAs, MAAs and post-approval changes, while mentoring a team of global CMC RA managers and coordinating with Process Development, Manufacturing, Quality and