Regulatory Submissions Manager (eu Ctr)- Turkiye

ICON Clinical Research, LP

Turkey
Eu ctr submissions
Uk-specific submissions
Cta/ind/maa experience
You will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team

Job Summary

  • You will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team.
  • Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA EU CTR and UK-specific submissions essential experience here required.
  • ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work life balance opportunities for you and your family.

Matching Summary

You will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team.

Skills & Requirements

Must-have

  • EU CTR submissions
  • UK-specific submissions
  • CTA/IND/MAA experience
  • central authority approvals
  • regulatory guidance
  • agency interactions

Nice-to-have

  • companion diagnostics
  • IVDR submissions
  • clinical performance studies
  • foster an inclusive environment
  • nurtures talent

Key Requirements

  • Minimum of 6 years of experience
  • Bachelor's degree in scientific or healthcare field
  • Advanced degree preferred
  • Ability to lead internal teams
  • Carry out regulatory activities independently

Work Rights

Not specified

Tailored Resume

Cover Letter