Paula Bennett

An experienced Regulatory Affairs professional with over 25 years’ experience, Paula has expertise in leading the regulatory strategy for and managing a wide range of regulatory submissions.

She advises on the regulatory approach and leads agency communications for all aspects of nonclinical and clinical drug development and drives submission preparation through to approval.

Paula’s substantial strategic and hands-on experience includes scientific advice (EMA CHMP advice [including pre-submission meetings and oral hearings] and National advice), orphan drug designations, paediatric investigation plans, PRIME designation, centralised MAAs, labelling development, authoring and reviewing of nonclinical/clinical CTD Modules for INDs, NDAs and MAAs, preparation of MAA Module 1, clinical trial applications and generic and well-established use applications.

Paula is a Member of The Organisation for Professionals in Regulatory Affairs (TOPRA).