Regulatory Affairs Associate (CMC)

PE Global ,
London, Greater London
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Overview

PE Global is currently recruiting for a Regulatory Affairs Associate (CMC) for a leading multi-national Biotech client in Uxbridge. The role: The Regulatory Professional under the direction of a Regional Regulatory Lead will lead compilation of CMC regulatory packages for submission and may be the lead for a program under supervision. Responsibilities: Collect and / or create country specific documents for regulatory filings worldwide. Compile and maintain CTA/MA documentation (e.g. variations, substantial amendments) in collaboration with Regional Regulatory Lead. Ensure compliance via timely submissions to regulatory agencies. Coordinate collection of functional documents in support of regulatory applications. As appropriate support execution of regulatory strategy. Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance. Requirements: Degree in a relevant discipline Previous regulatory affairs experience in pharma/biotech Interested candidates should submit an updated CV. Please click the link below to apply, call Amparo on 44 2039 669 800 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/89910676

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