Company
RegulatoryAffairsManager
Neural analysis suggests this role is
optimal for Senior candidates.
“Regulatory Affairs Manager. Skills: Regulatory Affairs, Health Authority Submission, Biologics, Cell & Gene Therapy. Prepare scientific information for Health Authority submission. Review scientific information for Health Authority submission”
What They're Looking For.
Must Have
Bachelor degree in Life sciences, More than 5 years of Regulatory CMC experience in innovation biologicals, Good understanding of innovation biologics, specifically Antibody, ADC and CGT products, Fluent in English
What You'll Do.
Prepare scientific information for Health Authority submission
Review scientific information for Health Authority submission
Prepare global customer submissions
Review global customer submissions
Respond to agency submission review questions
Prepare documents for pre-IND meetings
Prepare documents for pre-BLA meetings
Develop regulatory strategy
Support China QC testing
Provide internal regulatory support
Perform Regulatory assessments for change controls
Provide support for VCNs
Full Job Description
• 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
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