Senior Regulatory Specialist

1 day ago


Fatih, Istanbul, Turkey Parexel International Full time

Parexel International seeks a Senior Regulatory Specialist for upcoming positions in Istanbul or Ankara. This hybrid role requires one day of office work per month. The successful candidate will be accountable for performance and compliance with assigned protocols, adhering to ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements.

Key responsibilities include independently preparing submissions to both EC and RA, experience in EC and RA submission (familiarity with XML completion is an asset), ICF preparation using templates, local regulatory environment knowledge, submissions and approval processes understanding, and IMP supplies management at the local level.

Required Skills and Qualifications:
  • Mandatory - experience in EC and RA submission (ideally familiar with XML completion)
  • Experience in independently preparing submissions (CTC supports document collection) to both EC and RA
  • Experience in ICF preparation using templates
  • Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups
  • Experience in IMP supplies management at the local level
  • Experience in validation of translated documents

We offer exceptional training and development opportunities, exciting professional challenges, and a healthy work-life balance. We value your welfare just as highly as that of our patients.


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