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