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Integrated Regulatory Outsourcing Pharmaceutical Physician Jobs Medical Communication Jobs

Reference No: J18665

Regulatory Programme Manager \ Regulatory Affairs Manager
Based – Hertfordshire
Salary - £50,000 - £65,000 + competitive benefit package
Ref: J18665

Are you looking to work for a major Pharmaceutical organisation that embraces innovation, with an exciting product portfolio ?
Are you looking for structured career progression, both financially and professionally?
Do you want to work for one of the most reputable and respected businesses in the pharmaceutical industry?

Our client has an opportunity for an exceptional Regulatory Programme Manager / Regulatory Affairs Manager to join their global team to working specifically on their Immunology portfolio. You will be responsible for Phase II / III projects, ultimately resulting in MAA preparation and filing.
To the correct candidate the client will offer development of their knowledge and skills and offer further career opportunities locally and globally.

•Preparation/co-ordination of EU regulatory submissions
•Shall coordinate and lead regulatory submissions and manage registration procedures for a new MAA in the EU
•Support the strategy and registration activities in key countries outside of the EU.
•You ensure Affiliates are informed of project developments and activities

•Knowledge of EU legislation, guidelines and procedures,
•Management of regulatory submissions and procedures
•Direct interaction with Health Authorities and strategic regulatory input in drug discovery and development
•Strategic thinker and highly motivated
•University or higher degree in a scientific or technical discipline
•CTA experience is beneficial

If you are interested in this role please email your CV to or call Angelo Duarte on 01189 522797 to discuss further.
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to email this on to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 worth of vouchers of your choice.

Keywords: Development, EU, Regulatory, Affairs, Project, Programme, Manager, CTA, Hertfordshire, MAA, Submissions, Immunology, Europe, London, North, East, West, Essex, Bedfordshire, Buckinghamshire, Development, Pre approval, pre licensing, early phase

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