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Regulatory Affairs Professional - CTA/ EU-CTR (flexible location UK/EU)

United Kingdom, Remote Additional Locations: Belgrade, Serbia; Bucharest, Bucureşti, Romania; Budapest, Budapest, Hungary; Dublin, Dublin, Ireland; Madrid, Madrid, Spain; Milan, Milano, Italy; Prague, Czechia; Stockholm, Stockholm County, Sweden; Vilnius, Vilniaus Apskritis, Lithuania; Warsaw, Poland; Zagreb, Croatia Job ID R0000002514 Category Regulatory / Consulting
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About this Role

We are currently looking for Regulatory Affairs Professionals experienced in Clinical Trail Applications (CTAs) under EU-CTR directive. You can join us or our client dedicated projects and act as a Regulatory Affairs Consultant or Regulatory Affairs Senior Associate.

This role can be based in either UK or UE (home/office based).

In this role you will provide leadership in all regulatory and submissions related aspects of the clinical trial, you will be the main client contact and will be responsible with delivering submission specific milestones, while also providing guidance to the client on submissions strategies. You will be involved in EU CTR consulting and in operational aspects of EU CTR implementation and take on the role of Clinical Trial Submission Coordinator ensuring transversal collaboration between departments, working towards the delivery of all submissions of complex large clinical trials.

Ideal candidate will possess:

  • University degree in a science discipline

  • Background in clinical trial management

  • 2-5 years of experience in Regulatory Affairs

  • Good level of knowledge of the Clinical Trail Submissions on a local and regional level

  • Working knowledge of submissions under EU CTR direcitve

  • Project Management experience

  • Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.

  • Customer-oriented and autonomous

  • Fluency in English is a must along with the local language.

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