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Permanent Regulatory Submissions Manager

at Nikolay Dimitrov in United Kingdom

Regulatory Submissions Manager – Permanent


My client is a global CRO specializing in a number of therapeutic areas. As an addition to their headquarters in USA and operations worldwide, they are currently witnessing a rapid growth in their European activities.

On this occasion they are looking for Regulatory Submissions Managers to join their experienced and specialized clinical trial management teams in their offices in Germany, England and Scotland.

As a Regulatory Submissions Manager you will be responsible for managing and executing all aspects of global start-up. You will have background experience in clinical trials ideally within a Regulatory or Start-up role.


Key responsibilities:

• Perform quality checks on submission documents
• Provide advice regarding regulatory requirements for items such as labelling and submission documentation;
• Interact with international ethics committees and regulatory agencies;
• Be aware of changing regulations to develop proactive solutions to regulatory issues and challenges


Requirements:

• Minimum a Bachelor’s Degree in any related subject
• Knowledge of ICH guidelines and applicable local regulations regarding the conduct of clinical trials;
• Excellent written and oral skills;
• Advanced computer knowledge, especially with Microsoft® Office, is desired.


This is a fantastic opportunity to join a continuously growing company with an international team and further progress your career in a stimulating and challenging work environment.



Please send your CV to Nikolay.dimitrov@secpharma.com or call 0044 (0)20 7255 6600


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Contract Regulatory affairs Consultant – 6 months contract – Belgium at Nikolay Dimitrov in Belgium 16-06-2011

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Published at 20-06-2011
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