Regulatory Affairs Manager

1w1 week ago

Lonza

CN · Full-time · CNY 350,000 – CNY 650,000

About this role

The Regulatory Affairs Manager supports Lonza's biologics and cell & gene therapy network with China-focused regulatory activities. This role involves preparation and review of scientific information for Health Authority submissions, ensuring conformance with procedures. It targets global customer clinical, commercial variations.

Day-to-day tasks include reviewing responses to agency submission questions and preparing documents for pre-IND, pre-BLA meetings with Health Authorities. Develop regulatory strategies for biologics and CGT customers. Provide support for China QC testing needs.

Internal support covers operations and control, with understanding of EU, US, China regulatory requirements for contract manufacturing compliance. Perform regulatory assessments for change controls. Maintain transparency across the regulatory function.

Offer assistance to VCNs and project team queries as requested. Collaborate with global network sites to handle variations and strategies. Contribute to all phases of biological and CGT product manufacturing.

Requirements

More than 5 years of Regulatory CMC experience in innovation biologicals
Good understanding of innovation biologics, specifically Antibody, ADC and CGT products
Understanding of EU, US, China and other global regulatory requirements for biologics and CGT
Experience with Health Authority submissions and responses for biologics
Knowledge of CMC regulatory strategies for clinical and commercial variations
Fluent in English

Responsibilities

Prepare and/or review scientific and technical information suitable for Health Authority submission in conformance with applicable Lonza procedures
Prepare and/or review global customer China clinical, commercial variations from Biologics and Cell & Gene Therapy sites
Prepare and/or review responses to agency submission review questions for Biologics and Cell & Gene Therapy customers
Prepare documents to support global customer pre-IND, pre-BLA meetings with Health Authorities and develop regulatory strategy
Support global customer’s China QC testing for Biologics and Cell & Gene Therapy customers
Provide internal regulatory support for operations and control, including understanding of EU, US, China regulatory requirements
Perform Regulatory assessments for change controls
Provide support for VCNs and other project team queries