Regulatory Affairs Specialist

1 day ago


Fatih, Istanbul, Turkey Manpower Türkiye Full time

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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