CMC Regulatory Lead – Post-Market (ATMP/Oncology)

The Trust; Liverpool; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical organization is seeking an (Associate) Director for Post-Market Regulatory CMC to lead lifecycle strategy for Advanced Therapy Medicinal Products (ATMPs) and biologics. The role requires over 8 years of experience in Regulatory CMC with a strong focus on oncology products and post-approval CMC activities. Responsibilities include managing regulatory submissions, providing strategic input, and ensuring compliance with ever-evolving regulations. An advanced degree is preferred, and strong leadership and communication skills are essential.

Qualifications

• 8+ years in Regulatory CMC, Technical Development, Quality, or Manufacturing.
• Experience with ATMPs, cell therapy, and gene therapy.
• Strong understanding of regulatory requirements for oncology products.

Responsibilities

• Lead global post-market CMC regulatory strategy for ATMP and biologics.
• Oversee post-approval CMC supplements and ensure scientific accuracy.
• Manage responses to Health Authority queries.

Skills

CMC concepts unique to ATMP and biologics

Leadership

Communication

Project management

Analytical skills

Organizational capabilities

Education

Bachelor's, Master’s, or PhD in Cell Biology

Job description

A leading biopharmaceutical organization is seeking an (Associate) Director for Post-Market Regulatory CMC to lead lifecycle strategy for Advanced Therapy Medicinal Products (ATMPs) and biologics. The role requires over 8 years of experience in Regulatory CMC with a strong focus on oncology products and post-approval CMC activities. Responsibilities include managing regulatory submissions, providing strategic input, and ensuring compliance with ever-evolving regulations. An advanced degree is preferred, and strong leadership and communication skills are essential.