Regulatory Compliance Officer

6 days ago


Fatih, Istanbul, Turkey Parexel International Full time

Parexel International: A Global Leader in Clinical Research

We are seeking a skilled Senior Regulatory & Submissions Specialist to join our team in Istanbul or Ankara.

In this role, you will be accountable for ensuring performance and compliance with assigned protocols in a country, adhering to ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

About the Role:

  • Hybrid office-based position, requiring one day per month in the office.
  • Collaborate with cross-functional teams to ensure successful study execution.

Required Skills and Qualifications:

  1. Mandatory - experience in EC and RA submission, including initial submission and protocol amendments submission.
  2. Experience in independently preparing submissions (CTC supports with document collection) to both EC and RA.
  3. Experience in ICF preparation using templates.
  4. Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-ups.
  5. Experience in IMP supplies management at the local level (vendors providing background meds, standard of care, etc.).
  6. Experience in validation of translated documents.

As a valued member of our team, you will enjoy exceptional financial rewards, training, and development opportunities. You will also have the chance to work on exciting projects while maintaining a healthy work-life balance.


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