
Regulatory Compliance Officer
6 days ago
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:
- Mandatory - experience in EC and RA submission, including initial submission and protocol amendments submission.
- Experience in independently preparing submissions (CTC supports with 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 (vendors providing background meds, standard of care, etc.).
- 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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