Lene Nielsen

Lene collaborates with clients to make sure their regulatory deadlines are met throughout the product development process in the most effective way possible.

With over 20 years of experience in the pharmaceuticals sector and a strong background in leadership, Lene has a global perspective in R&D, QA, DD, and GRA CMC for all stages of a medical product. This includes Phase I through to Phase III, NDA/MAA and new Marketing applications as well as Post Marketing with an emphasis on CMC components.

Lene has experience in the fields of diabetes, rare diseases, oncology, and haemophilia. Some of the platforms on which she has worked include recombinants, plasma, generics/biosimilars, and gene therapy.

She has also participated in due diligence investigations for the GRA CMC and CMC parts and party agreements through Phase I – III, MAA/NDAS and post marketed products

Prior to VCLS, Lene worked at, Novo Nordisk A/S in GRA CMC as Professional and Head of GRA CMC departments, QA department head and R&D CMC as Senior Project Lead on Semaglutide in Tablets, Head Local and Global GRA for in-licensed products in  Actavis, Teacher at Copenhagen University, Lead Pharmacist at different Danish Pharmacies, Tesaro as Senior Consultant setting up the EU organizations and support EMA MAA, Building Early Access programs, CSL Behring as Head of 3 departments covering Plasma products, Gene Therapy and Recombinants globally, and Vesifact – focus on mapping CBD commercial/wellness options.

MSc in Pharmacy, Managing Medical Product Innovation (CBS), Business Development (Cranfield University)

Lene is based at our Lausanne office in Switzerland.