Regulatory Submissions Manager (eu Ctr)- Turkiye

ICON

Turkey
Regulatory submissions management
Eu ctr and uk-specific submissions
Clinical trial applications
As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team

Job Summary

  • As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team.
  • ICON offers a diverse culture that rewards high performance and nurtures talent, with benefits focused on well-being and work-life balance.
  • ICON is committed to providing an inclusive and accessible environment for all candidates and a workplace free of discrimination and harassment.

Matching Summary

As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team.

Skills & Requirements

Must-have

  • Regulatory submissions management
  • EU CTR and UK-specific submissions
  • Clinical trial applications
  • Marketing authorization applications
  • Regulatory agency interactions
  • Regulatory guidance provision

Nice-to-have

  • Companion diagnostics experience
  • IVDR submissions knowledge
  • Clinical performance studies experience
  • Cross-functional team collaboration
  • Development of best regulatory practices

Key Requirements

  • Bachelor's degree in scientific or healthcare field
  • Minimum 6 years regulatory affairs experience
  • Experience with CTA/IND/MAA submissions
  • Ability to lead internal teams independently
  • Strong understanding of global regulatory guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter