Regulatory Affairs Manager

• Preparation and/or review of scientific and technical information suitable for Health Authority submission in conformance with applicable Lonza procedures.
• Preparation and/or review of global customer China clinical, commercial, variations etc. from global network Biologics and Cell & Gene Therapy sites.
• Preparation and/or review of responses to agency submission review questions for Biologics and Cell & Gene Therapy network customers.
• Preparation of documents to support global customer pre-IND, pre-BLA, etc. meeting with Health Authorities and development of regulatory strategy for Biologics and Cell & Gene Therapy network customers.
• Support on global customer’s China QC testing for Biologics and Cell & Gene Therapy network customers
• Internal regulatory support for operation and control o    Understanding of EU, US, China and other global regulatory requirements to support compliance in all phases of contract manufacturing of Biological and Cell & Gene Therapy products. o    Maintain transparency of information across regulatory function.
• Perform Regulatory assessments for change controls
• Provide support for VCNs and other project team queries, as requested.

    Qualifications

• Degree :Bachelor
• Field of Study:Life sciences
• More than 5 years of Regulatory CMC experience in innovation biologicals.
• Good understanding of innovation biologics, specifically Antibody, ADC and CGT products.
• Good understanding of innovation biologics, specifically Antibody, ADC and CGT products.
• Fluent in English