Torsten Kuiper
Associate Director Regulatory Affairs CMC at Novartis | Basel, Basel, Switzerland
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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.
Associate Director Regulatory Affairs CMC at Novartis in August 2020 to Present
Principal Scientist / Functional Lead at Novartis in November 2018 to July 2020
Principal Scientist / Project manager at Novartis Institutes for BioMedical Research (NIBR) in September 2017 to September 2018
Principal Scientist / Lab Head / Project manager at Novartis Institutes for BioMedical Research (NIBR) in December 2012 to September 2017
Lab Head at Novartis Institutes for BioMedical Research (NIBR) in July 2010 to November 2012
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CMC Regulatory Affairs
Regulatory Submissions
Regulatory Affairs
Pharmaceutical Research
Drug Development
Bioanalysis
Pharmaceutical Industry
Project Management
Biotechnology
Biopharmaceuticals
Analytical Biochemistry
Protein Characterization
ELISA
Pharmacokinetics
Binding Assays
LC-MS
SPR
Protein Microarrary
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Discover more about NovartisWhat is Torsten Kuiper email address?
Email Torsten Kuiper at [email protected]. This email is the most updated Torsten Kuiper email found in 2026.
How to contact Torsten Kuiper?
To contact Torsten Kuiper send an email to [email protected]. (updated on November 04, 2024)
What company does Torsten Kuiper work for?
Torsten Kuiper works for Novartis
What is Torsten Kuiper's role at Novartis?
Torsten Kuiper is Associate Director Regulatory Affairs CMC
What is Torsten Kuiper's Phone Number?
Torsten Kuiper's phone (**) *** *** 197
What industry does Torsten Kuiper work in?
Torsten Kuiper works in the Pharmaceutical Manufacturing industry.
Torsten Kuiper Email Addresses
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