Regulatory & Submissions Expert

2 days ago


Fatih, Istanbul, Turkey Parexel International Full time

As a key member of the Parexel International team, the Senior Regulatory Specialist will play a crucial role in ensuring compliance and performance in assigned protocols. This position is based in Istanbul or Ankara, with one day of office work required per month. The ideal candidate will possess strong knowledge of ICH/GCP and country regulations, as well as experience in EC and RA submission, including XML completion.

The Senior Regulatory Specialist will be responsible for independently preparing submissions to both EC and RA, utilizing their skills in ICF preparation using templates, local regulatory environment knowledge, and submissions and approval processes understanding. Additionally, they will manage IMP supplies at the local level and validate translated documents.

Key Responsibilities:
  1. Independently preparing submissions to both EC and RA
  2. EC and RA submission experience (XML completion familiarity is an asset)
  3. ICF preparation using templates
  4. Local regulatory environment knowledge
  5. Submissions and approval processes understanding
  6. IMP supplies management at the local level

Parexel International offers a dynamic work environment, career growth opportunities, and a commitment to employee wellness.


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