Global CMC Regulatory Leader – Cell & Gene Therapy

Miltenyi Biotec; Trenton (NJ); On-site; USD 250,000 - 272,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

401(k) plan

Bonuses or commissions

Job summary

Miltenyi Biotec is seeking a senior leader to guide global CMC regulatory affairs for our cell and gene therapies. You will supervise a team of managers, shape regulatory strategies across development, registration and lifecycle, and ensure compliance with global requirements.

The role requires extensive CGT regulatory experience, strong communication and leadership skills, and seamless collaboration with cross‑functional teams to drive strategic regulatory outcomes worldwide.

Qualifications

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline.
• +12 years demonstrated hands‑on expertise in Chemistry, Manufacturing & Controls (CMC) Regulatory Affairs for Cell & Gene Therapy (CGT) products is mandatory.
• Extensive experience in Regulatory Affairs within biotech/pharma environments.
• Proven experience supporting global regulatory submissions and health authority interactions (EU/US).
• Deep understanding of biologics, ATMPs, CGT products and global regulatory frameworks.
• Excellent communication, leadership and project management skills.
• Fluent English written and verbal communication.

Responsibilities

• Lead and mentor a global team of CMC RA managers for CGT products.
• Oversee development and approval of CMC sections for regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, post‑approval variations).
• Provide strategic guidance on manufacturing processes, analytics, specifications, comparability studies and control strategies.
• Assess regulatory impact of manufacturing changes and define global pathways.
• Support interactions with FDA, EMA, MHRA and other agencies in collaboration with local RA teams.
• Collaborate with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development.
• Monitor regulatory trends and translate them into strategy and risk mitigations.

Skills

CMC Regulatory Affairs

Regulatory Strategy

Global Submissions

Leadership

Communication

English Proficiency

CGT/ATMP

Education

Master's or PhD in Pharmacy/Biotech/related

Job description

Miltenyi Biotec is seeking a senior leader to guide global CMC regulatory affairs for our cell and gene therapies. You will supervise a team of managers, shape regulatory strategies across development, registration and lifecycle, and ensure compliance with global requirements.

The role requires extensive CGT regulatory experience, strong communication and leadership skills, and seamless collaboration with cross‑functional teams to drive strategic regulatory outcomes worldwide.