Lonza Group is seeking a Regulatory Affairs Manager with extensive experience in regulatory CMC for biologics and cell & gene therapy products. The ideal candidate will have a strong background in compliance and regulatory strategy, particularly in relation to global health authorities
Job Summary
The role involves preparing and reviewing scientific information for Health Authority submissions in compliance with company procedures.
Candidates will develop regulatory strategies for global customers regarding pre-IND and pre-BLA meetings for Biologics and Cell & Gene Therapy products.
The position requires supporting China QC testing and performing regulatory assessments for change controls within the network.
Matching Summary
Match Score: 85
Lonza Group is seeking a Regulatory Affairs Manager with extensive experience in regulatory CMC for biologics and cell & gene therapy products. The ideal candidate will have a strong background in compliance and regulatory strategy, particularly in relation to global health authorities.
Skills & Requirements
Must-have
5+ years Regulatory CMC experience
Innovation biologics knowledge
Antibody ADC CGT product expertise
Health Authority submission preparation
Global regulatory strategy development
Nice-to-have
Fluent English communication skills
China QC testing support experience
Internal regulatory process transparency
Change control assessment capability
Key Requirements
Bachelor's degree in Life Sciences
More than 5 years of Regulatory CMC experience
Understanding of EU, US, and China regulatory requirements