Regulatory Affairs Manager (EU - Oncology)

PE Global ,
High Wycombe, Buckinghamshire
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Overview

PE Global is currently recruiting for a Regulatory Affairs Manager (EU - Oncology) for a leading multi-national Pharmaceutical client in High Wycombe. Responsibilities: • Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates • Drive understanding of central and national regulatory requirements • Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan • Advise team on required documents and submission strategies in preparation of CTA • Ensure CTA submission packages are complete and available according to agreed timelines • Provide regulatory support throughout life-cycle management • Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate) Requirements: • University degree • Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas) • Experience with EU regulatory procedures (CP, MRP, national) • Previous Oncology experience required 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/89906879

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