
Senior Regulatory
6 days ago
REGISTER YOUR INTEREST
Parexel International invites applications for Senior Regulatory & Submissions Specialist positions in Istanbul or Ankara.
We will promptly send you an email invitation to officially apply once the role becomes available. Thank you for your interest.
The position is hybrid office-based, requiring one day per month in the office.
Key Responsibilities:
- Ensure performance and compliance with assigned protocols in a country in accordance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
Essential Skills and Qualifications:
- Mandatory - experience in EC and RA submission (ideally familiar with XML completion), 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.
We offer exceptional financial rewards, training, and development opportunities. You can expect exciting professional challenges with a healthy work-life balance. We value your welfare just as highly as that of our patients.
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