Regulatory Affairs Professional

2 days ago


Fatih, Istanbul, Turkey Parexel International Full time

This Senior Regulatory Specialist position at Parexel International involves ensuring compliance and performance in assigned protocols. The role is based in Istanbul or Ankara, with one day of office work required per month. The ideal candidate will possess experience in EC and RA submission, including XML completion, as well as strong knowledge of the local regulatory environment and submissions and approval processes.

Main responsibilities include:

Main Responsibilities:
  1. Preparation of submissions to both EC and RA
  2. EC and RA submission experience (ideal familiarity with XML completion)
  3. Preparation of ICF using templates
  4. Management of IMP supplies at the local level
  5. Validation of translated documents

Parexel International offers a dynamic work environment, competitive benefits, and opportunities for career growth.



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