Kulminder Nowacki

Director, Regulatory Science Drugs & Biologics

 

As Director Regulatory Science Drugs and Biologics, Kulminder works in close collaboration with life sciences companies to provide strategic input and regulatory support for MAA submissions and for the lifecycle management activities of innovative drugs and biologics.

She brings to the role more than 15 years of experience in the pharma industry. During this time, she has managed the registration and license maintenance of a variety of drugs and biologics in a number of therapeutic areas, including anti-infective, anti-viral, women’s health, endocrinology (including epilepsy) and controlled drug products, in Europe, Switzerland and ROW (MENA) countries and has led cross functional teams involving CMC, Quality, Supply Chain, Contract Manufacturers, Market Access, Medical Affairs and Clinical teams to ensure delivery of agreed regulatory projects.

In particular, Kulminder has extensive experience in the preparation and successful submission of MAAs for rare/orphan medicinal products through the Centralized Procedure.

This has involved leading, arranging and attending meetings with the EMA including participation in several oral explanations (CMD(h), CHMP and SAG) and interaction with the scientific committees at the EMA (PRAC, CHMP, COMP, PDCO and CAT) pre, during and post MAA submissions. Kulminder also has significant experience working with a number of key EU National Health Authorities.

Kulminder started her career at Huntington Life Sciences before joining Icon Clinical as a consultant and later TMC Pharma Services. She also held various positions in Regulatory Departments at Wyeth/Pfizer and Viro Pharma where she successfully registered the first Paediatric Marketing Authorisation (PUMA) in 2011.

Before joining VCLS, Kulminder was employed by Aegerion Pharmaceuticals as Director Regulatory Affairs, with responsibility for Europe, Middle East & Africa.

Kulminder was awarded a BSc (Hons) degree in Applied Chemistry from the University of Nottingham, UK and is based in the UK at the Voisin Camberley office.

 

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