tranScrip is delighted to announce the appointment of Paula Bennett.
Paula joins tranScrip as a Partner and brings over 25 years’ experience in the pharmaceutical industry. An experienced Regulatory Affairs professional, 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 (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 the nonclinical/clinical CTD Modules, preparation of Module 1, National clinical trial applications and generic and well-established use applications.
Paula is a Member of The Organisation for Professionals in Regulatory Affairs (TOPRA).
Marcin Mankowski, tranScrip’s Managing Partner said, “I am delighted to welcome Paula to tranScrip. She has collaborated closely with us over the last several years, providing regulatory support to many of our clients and I am very happy she has agreed to formally become part of our team.”