
Regulatory Affairs Specialist
1 day ago
We are seeking a highly qualified Regulatory Affairs Specialist to join our team at Manpower Türkiye. The ideal candidate will have extensive experience in regulatory affairs and strong analytical skills.
About the Position:
- Ensure compliance with regulatory agency regulations and interpretations.
- Prepare responses to regulatory agencies' questions and other correspondence.
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
Key Accountabilities:
- Ensure compliance with regulatory agency regulations and interpretations.
- Prepare responses to regulatory agencies' questions and other correspondence.
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
- Develop timelines for submissions under the direction of senior regulatory affairs staff.
- Provide regulatory advice to project teams. Organize and maintain reporting schedules for new drug / new medical device application and renewals.
- Conduct global regulatory impact assessments for all changes at the manufacturing sites and ensure submission of relevant changes if needed.
- Review and approve text drafts and artworks of labels packaging and instructions for use for assigned products. Translate and draft additional labels according to Turkish requirements.
- Support the Regulatory Affairs part of audits.
This is a Mid-Senior level position that requires full-time commitment.
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