Global CMC Regulatory Leader for Cell & Gene Therapy

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

Benefits offered by this job

Health, vision and dental insurance

401(k) plan

Bonuses or commissions

Job summary

Miltenyi Biomedicine Inc. seeks a senior Regulatory Affairs Lead for Chemistry, Manufacturing & Controls (CMC) in CGT. You will lead a global team, shaping regulatory strategy across development, registration and lifecycle management while ensuring compliance with global requirements.

The role centers on strategy, submissions, and interactions with health authorities worldwide, with a focus on cell and gene therapies and ATMPs. Strong leadership and English skills are essential.

Qualifications

• Master's degree or PhD in a scientific discipline is mandatory.
• Extensive experience in Regulatory Affairs within biotech/pharma.
• Experience supporting global submissions and health authority interactions (EU/US).
• Deep understanding of biologics, ATMPs, CGT, and global regulatory frameworks.
• Excellent communication, leadership and project management skills.
• Fluent written and spoken English.

Responsibilities

• Lead global CMC RA managers and provide regulatory leadership for CGT products.
• Develop strategy and review CMC sections for INDs, CTAs, BLAs, MAAs, amendments.
• Guide regulatory requirements for manufacturing, analytics, specs, and changes.
• Assess regulatory impact of manufacturing changes and define pathways.
• Support interactions with FDA, EMA, MHRA and other agencies.
• Collaborate with PD, Manufacturing, Quality, Supply Chain and Clinical.
• Monitor regulatory developments and translate into strategies.
• Drive risk assessments and mitigations across product lifecycle.

Skills

Regulatory Affairs

Leadership

Project management

English proficiency

Biologics CGT knowledge

Strategic regulatory submissions

Education

Master’s or PhD in Pharmacy/Biotechnology/Biology/Chemistry

Job description

Miltenyi Biomedicine Inc. seeks a senior Regulatory Affairs Lead for Chemistry, Manufacturing & Controls (CMC) in CGT. You will lead a global team, shaping regulatory strategy across development, registration and lifecycle management while ensuring compliance with global requirements.

The role centers on strategy, submissions, and interactions with health authorities worldwide, with a focus on cell and gene therapies and ATMPs. Strong leadership and English skills are essential.