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Regulator CTA Submission Manager

  1. Home Counties
  1. Contract
Competitive
25368
  1. Drug Safety / Pharmacovigilance
Date Posted25 Aug 2020

This vacancy has now expired

Regulator CTA Submission Manager - Contract 3 months - Buckinghamshire

Are you looking for your next contract?  Are you searching for that exciting CTA opportunity?

We have been appointed by our Pharmaceutical leader to search and a CTA lead for an exciting new project based in the desired location of leafy Buckinghamshire.


This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).

 
  • The Regulatory Clinical Trial Application submission manager has experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
  • The Regulatory Clinical Trial Application submission manager will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.). 
  • Successful candidates for this position have: in depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.

We are offering a very competitive rate and the opportunity of working in a rewarding and exciting team.

If this is of interest to you, please do get in touch.

The candidate must have the rights to work in the location stated in the job advert.

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