
Senior Regulatory Specialist
1 day ago
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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Senior Regulatory
5 days ago
Fatih, Istanbul, Turkey Parexel International Full timeREGISTER YOUR INTERESTParexel 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...
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Regulatory & Submissions Expert
1 day ago
Fatih, Istanbul, Turkey Parexel International Full timeAs 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...
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Regulatory Affairs Expert
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Fatih, Istanbul, Turkey Parexel International Full timeSenior Regulatory & Submissions Specialist OpportunitiesParexel International invites applications for Senior Regulatory & Submissions Specialist positions in Istanbul or Ankara.In this role, you will be responsible for ensuring performance and compliance with assigned protocols in a country, adhering to ICH/GCP and country regulations, Client policies and...
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Regulatory Affairs Professional
1 day ago
Fatih, Istanbul, Turkey Parexel International Full timeThis Senior Regulatory Specialist position at Parexel International involves ensuring compliance and performance in assigned protocols. The role is based in Istanbul or Ankara, with one day of office work required per month. The ideal candidate will possess experience in EC and RA submission, including XML completion, as well as strong knowledge of the local...
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Regulatory Compliance Officer
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Ice Cream Regulatory Compliance Specialist
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Fatih, Istanbul, Turkey Unilever Full timeAs a member of our team, you will be responsible for leading innovations and driving growth in Türkiye within the METSA Ice Cream Regulatory team end to end. You will collaborate with brilliant business leaders and colleagues in a truly global and diverse culture to ultimately become a better you.About the Role:Compliance: Develop and implement regulatory...
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Ice Cream Regulatory Specialist
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