Senior Director, Global CMC Regulatory Affairs — CGT

US Diversity Job Search; Washington (District of Columbia); On-site; USD 250,000 - 272,000; Full time

Benefits offered by this job

Health, vision, and dental insurance

401(k) plan

Bonus opportunities

Job summary

Miltenyi Biomedicine Inc. seeks a senior regulatory leader to oversee global CMC RA for Cell & Gene Therapies, guiding development, registration and lifecycle management to ensure global compliance.

The role leads a team of global CMC RA managers, providing regulatory strategy for submissions (INDs, CTAs, BLAs, MAAs) and interacting with FDA/EMA while collaborating with Process Development, Manufacturing, Quality and Clinical Development.

Qualifications

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related field with 12+ years in CMC Regulatory Affairs for CGT.
• Extensive experience supporting global regulatory submissions and health authority interactions (US/Europe).
• Deep understanding of biologics, ATMPs, CGT products and global regulatory frameworks.
• Excellent communication, leadership and project management skills.

Responsibilities

• Lead global CMC RA managers and provide regulatory leadership across development, registration and lifecycle management.
• Oversee strategy and review of CMC sections for INDs, CTAs, BLAs, MAAs, amendments and post-approval variations.
• Provide guidance on manufacturing, analytical methods, comparability studies and process validation.
• Assess regulatory impact of manufacturing changes and define global pathways.
• Collaborate with FDA, EMA, MHRA and other agencies with local RA partners.
• Coordinate with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development.
• Monitor regulatory developments and translate them into strategies; drive risk assessments.

Skills

Regulatory leadership

CMC strategy

Global submissions

Cross-functional leadership

English fluency

CGT knowledge

Education

Master's/PhD in sciences

Job description

Miltenyi Biomedicine Inc. seeks a senior regulatory leader to oversee global CMC RA for Cell & Gene Therapies, guiding development, registration and lifecycle management to ensure global compliance.

The role leads a team of global CMC RA managers, providing regulatory strategy for submissions (INDs, CTAs, BLAs, MAAs) and interacting with FDA/EMA while collaborating with Process Development, Manufacturing, Quality and Clinical Development.