Regulatory Affairs (CTA submissions)

PE Global ,
London, Greater London
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Overview

PE Global is currently recruiting for a Regulatory Affairs (CTA submissions) for a leading multi-national Biotech client in Cambridge / Uxbridge. Responsibilities: The Regulatory Professional will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations) Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications Review regional component of the Global Regulatory Plan and provide input to operational deliverables Ensure compliance via timely submissions to regulatory agencies Support RRL in review of promotional materials for commercial activities (ex-US) Collaborate with CROs / partners to support site initiation Requirements: Previous experience in a similar role in Biotech 3rd level degree in a relevant discipline Strong communication skills Understanding of drug development process Interested candidates should submit an updated CV. Please click the link below to apply, call Amparo on 203 86 86 203 or alternatively send an up to date CV Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job was originally posted as www.totaljobs.com/job/89942636

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