Torsten Kuiper serves as the Associate Director of Regulatory Affairs CMC at Novartis, where he leverages over 15 years of extensive experience in biopharmaceutical research and drug development. His expertise lies at the intersection of regulatory compliance and scientific innovation, particularly in the lifecycle management...
Torsten Kuiper serves as the Associate Director of Regulatory Affairs CMC at Novartis, where he leverages over 15 years of extensive experience in biopharmaceutical research and drug development. His expertise lies at the intersection of regulatory compliance and scientific innovation, particularly in the lifecycle management of marketed biologics and clinical products. Torsten has a proven track record in managing complex regulatory submissions, including New Drug Applications (NDA) and Marketing Authorization Applications (MAA), as well as variations that ensure product integrity and compliance with evolving regulatory standards.
At Novartis, Torsten leads cross-functional project teams, focusing on the developability assessment of novel therapeutic drug candidates. His strong background in analytics and in-vivo characterization enables him to provide critical insights that facilitate smooth project transitions from development to commercialization. He is adept at resource allocation, budget management, and performance oversight, ensuring that lab teams operate efficiently while meeting stringent regulatory requirements.
Torsten's proficiency in CMC Regulatory Affairs is complemented by his skills in bioanalysis, protein characterization, and advanced assay techniques such as ELISA and binding assays. His involvement in life-cycle management and line extensions for marketed biologics underscores his commitment to maintaining product quality and regulatory compliance throughout the product's lifecycle. As a dedicated professional in the pharmaceutical industry, Torsten Kuiper continues to drive innovation and regulatory excellence at Novartis, contributing to the development of safe and effective biopharmaceuticals that meet patient needs.
