Associate Director, Regulatory Affairs CMC

Regulatory Affairs Manager

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Closing Date: 29/05/2020

Location/Division: UK

 

Associate Director Regulatory Affairs CMC - UK

 

Global Regulatory Team

 

 

 

Please note we now require all external candidates to read and sign a copy of our transparency statement and upload this with their application. If this is not submitted with their application/CV your data will be removed immediately from our system in line with GDPR regulations.

 

We are currently looking for a Associate Director, Regulatory Affairs CMC to join our commercial team in the Global HQ UK.

 

This role is responsible for providing CMC regulatory leadership and guidance to project teams, manufacturing /Supply and QA departments for a mixed portfolio of marketed products. It involves responsibility for authoring and oversight of quality dossiers to support clinical trial applications, PIPS and module 3 leaf’s for applications in the EU, U.S. and multiple international territories. It will involve working closely with regulatory external CMC individuals and interacting with global health authorities to achieve alignment on the regulatory strategies to achieve and maintain product registration.

 

Company Overview

 

We are a global speciality pharmaceutical company, continuously striving to confront current gaps in patient care. Our ambition drives us to deliver medical treatments that deliver real change to improve patients’ lives wherever they are needed in the world.

 

For more information about the company, please visit our website: www.eusapharma.com    

 


 

Please see attached job description for further information. If you are interested in this role, please apply below with a covering letter of why you may be suitable along with an up to date version of your CV. 

 

Please note we now require all external candidates to read and sign a copy of our transparency statement and upload this with their application.

 


EUSA Pharma is a dynamic and rapidly growing pharmaceutical company. We are constantly looking for highly talented individuals who, like us, are passionate and committed to helping patients live and embrace life.



If you are interested in joining our journey and if you share our values and ambition - please contact us.



We Care, We Deliver, We Respect, We are Ambitious and We Adapt


 

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