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Long-term collaboration for Clinical Trial Application and IND-Process

  • Regulatory services - CMC writing - medical writing
  • Human Medicines
  • Europe
  • 07/31/2012

Description

A globally acting large pharma company looks for a regulatory consultancy for a long-term collaboration that has indepth practical and operational experience with all aspects of the EU CTA process. You should be working at the interphase between the agencies and our in-house groups, collecting all necessary information and data, ensuring that all required data are collected, kept and reported adequately. Preparation of the necessary application forms and documentations, communication with the agencies, reporting back to the in-house groups. IMPD/IB preparation is planned to stay in-house but this has not yet fully be decided.

In the EU, experience in CTA-processing with all national agencies is required.

FDA-IND experience is also requested, eventually also acceptable via a partner/agent in the US. But this is not a must-criterion.
Please respond in your application on the specifically described expectations - how much of this CTA business is your daily business, how detailed are you involved and how much do you understand the requirements for the companies in the various EU countries before, during and after CTA submissions.

Requirements

  • Proven hands-on experience
  • Knowledge on the requirements in the various EU countries

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