Natasha Nesterova-smith
Associate Director, Regulatory Affairs
Pharma
Boyd Consultant Ltd.
Spain
Biography
Natasha is a Regulatory Affairs professional with over 14 years regulatory experience in drug development and registrations for biological and small molecules, including orphan drugs: clinical development, scientific advice and pre-submission meetings, MAA, paediatric investigation plans and lifecycle management for EU centrally approved products. Natasha’s particular experience lies across the therapeutic areas of oncology and transplant (NCE); immunology, enzyme-replacement therapy (biotechnology), HRT, CNS and cardiovascular. Qualifying at St Petersburg State Academy of Chemistry and Pharmacy, Natasha worked in Russia for a number of years as Head of Hospital Pharmacy and as a Pharmaceutical Consultant. In 2001, Natasha moved to Regulatory Affairs at AMGEN and from there has held Regulatory positions at PAREXEL International, Transkaryotic Therapies (now Shire), Genzyme and more recently at REGEM Consulting as a Regulatory Consultant. Natasha, a member of TOPRA, brings her expertise in project management to the team at Boyds. She is a confident communicator with regulatory authorities, clients and project team members.
Research Interest
drug development and registrations for biological and small molecules, including orphan drugs
