• 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
Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.
Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.
For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.
