Dianne Lee
Chief Executive Officer @DLRC Regulatory Consultancy
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WORK HISTORY
Chief Executive Officer @DLRC Regulatory Consultancy
ABOUT DIANNE LEE
I have worked in the Pharmaceutical Industry for 40 years starting in R&D, moving to Regulatory Affairs in 1987. I have been a Fellow of TOPRA (The Organisation for Professional in Regulatory Affairs) since 2001. My first degree was a BSc in Applied Biology specialising in pharmacology and toxicology and In 2020 was awarded a Diploma in Developing board Performance from the Institute of Directors.In 1995 I left my role as Director of Regulatory Affairs at Serono to become an independent regulatory consultant, working for numerous clients on a broad range of products. I have direct experience of pharmaceuticals, biological/biotechnology products and OTC medicines covering most aspects of their registration including preparation and submission of scientific advice packages, submission and management of clinical trials from Phases I-IV, submission of national/DCP/Centralised MAAs for full and abridged applications, maintenance of national and centralised licences through variation and renewal, development of labelling and certification of advertising materials. Therapeutic areas covered include Oncology, Anti-infectives, Neurology, Infertility, Cardiovascular, Pain management and Vaccines.Since 2017 I have focussed on managing DLRC as the company grows and expands its offering to clients.Specialities: Regulatory strategy; regulatory consultancy; regulatory project management; clinical trial and marketing authorisation applications; regulatory agency liaison and negotiation - EMA, MHRA, HPRA, MPA, BfArM; lifecycle management; vaccines; consumer healthcare; oncology; company management
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