Director of Regulatory Affairs – Berkshire, UK

Our client, a global pharmaceutical company based in Berkshire, is currently looking for a Director of Regulatory Affairs to join their team.

As the Director of Regulatory Affairs you will provide European regulatory guidance and strategy to your regulatory colleagues and global project teams leading to sound scientific development programs and successful registration for new biological compounds and new indications.

This Director of Regulatory Affairs role will also include the following key responsibilities:

  • You will liaise, negotiate and partner with European Regulatory Agencies. Represent the company during Agency (National/EMA) interactions
  • Schedule and lead meetings with Agencies and prepare company personnel for Agency interactions.
  • Determine the content for the Quality related section of regulatory submissions as well as evaluate submissions for accuracy.
  • You will also prepare regulatory responses to requests from health authorities and meet aggressive deadlines to ensure that regulatory Agencies receive timely and scientifically robust submissions, shortening the review process and leading to successful approval of biological products for the company’s growth thereby accomplishing corporate goals.

 

What makes this Director of Regulatory Affairs role different?

Our Client is truly a leader in its field. You can expect a smaller company feel providing you with room to grow and influence others but with the financial backing and security of an established corporate organisation. If you want to not only make a difference to the end users and patients but also help shape the way that the European Regulatory department function then this is an ideal opportunity. It will give you strategic and operational input and responsibilities.

 

Apply now

For more information, or to apply for this Director of Regulatory Affairs position, please contact Jonathan Hart-Smith on 01438 743047 or email: jhartsmith@ckclinical.co.uk.

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