Clinical Trial Submission Manager Associate

ICON

Istanbul, Turkey
Regulatory submission management
Notification to ecs and ra
Amendment submission via ra portal
As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies

Job Summary

  • As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
  • The position involves managing notifications, amendments, and submissions to Ethics Committees and Regulatory Authorities, including printing and shipping dossiers and managing payments and follow-ups.
  • ICON offers a diverse and inclusive culture with competitive salary and a range of benefits focused on well-being and work-life balance for employees and their families.

Matching Summary

As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Skills & Requirements

Must-have

  • Regulatory submission management
  • Notification to ECs and RA
  • Amendment submission via RA portal
  • Payment management to ECs
  • Fluent in Turkey regulatory process
  • 100% office based in Istanbul

Nice-to-have

  • Strong attention to detail
  • Excellent communication skills
  • Involvement in global regulatory activities
  • Support to Regional Study Managers
  • Familiarity with label review and translation

Key Requirements

  • Bachelor's degree in scientific or healthcare field
  • 1-2 years regulatory affairs experience
  • Knowledge of CT/IND, MAA/NA, DSUR, PSUR submissions
  • Familiarity with pharmaceutical or biotechnology industry
  • Fluency in Turkish regulatory processes

Work Rights

Not specified

Tailored Resume

Cover Letter