Regulatory Affairs Specialist

  • Full time
  • Prague
  • Posted 4 days ago

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Role

This role offers the right candidate the opportunity to join a fast growing and developing Global Regulatory Affairs team. The Regulatory Affairs Associate (RAA) manages the activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/countries.

Summary of tasks:

  • Management of country level submissions associated with ensuring Investigational Product and any other clinical trial supplies can be imported / exported into/from the country the LRAA is responsible for.
  • Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
  • Management of the country level Informed Consent and any other documentation given to patients through to submission and approval by country level RA and Central IEC as appropriate.
  • Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
  • Perform role of Local Reviewer in the QC process as appropriate.
  • Providing consultancy to the client on any country specifics issues if requested
  • You are:

    A quality focused self-starter with ambition to learn and develop.

    Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

  • An undergraduate degree ideally in science, or health-related field.
  • Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
  • The ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
  • Strong communication skills and fluency in written and spoken English and local language
  • To apply for this job please visit cz.talent.com.