Global CMC Regulatory Director for Cell & Gene Therapy

Miltenyi Biotec; Annapolis (MD); On-site; USD 250,000 - 272,000; Full time

Benefits offered by this job

Health insurance

Vision & dental insurance

401(k) plan

Bonus/commissions eligibility

Job summary

Miltenyi Biomedicine Inc. seeks a Senior Global Regulatory Leader for Chemistry, Manufacturing & Controls (CMC) within Cell & Gene Therapy to guide regulatory strategy and lifecycle management for CGT products.

You will lead a team of global CMC regulatory managers and shape development, registration, and post-approval activities. The role requires extensive regulatory affairs expertise in biotechnology/pharma, with interactions with FDA/EMA and other authorities, and collaboration across

Qualifications

• 12+ years hands-on CMC Regulatory Affairs experience for CGT products
• Experience supporting global regulatory submissions and interactions with health authorities (FDA/EMA)
• Deep understanding of biologics, ATMPs, CGT products and global regulatory frameworks

Responsibilities

• Lead global CMC regulatory strategies for CGT products throughout development and lifecycle
• Review and approve CMC sections for submissions (INDs, CTAs, BLAs, MAAs, amendments)
• Provide guidance on regulatory requirements for manufacturing processes, analytics, specs, and process validation
• Assess regulatory impact of manufacturing changes and define pathways worldwide
• Interact with health authorities and collaborate with cross-functional teams
• Monitor regulatory developments and translate them into strategy
• Conduct regulatory risk assessments and mitigation plans

Skills

Regulatory leadership

CMC regulatory affairs

Global regulatory strategy

Regulatory submissions

Leadership & project management

Fluent English

Education

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

Job description

Miltenyi Biomedicine Inc. seeks a Senior Global Regulatory Leader for Chemistry, Manufacturing & Controls (CMC) within Cell & Gene Therapy to guide regulatory strategy and lifecycle management for CGT products.

You will lead a team of global CMC regulatory managers and shape development, registration, and post-approval activities. The role requires extensive regulatory affairs expertise in biotechnology/pharma, with interactions with FDA/EMA and other authorities, and collaboration across