Senior Regulatory Professional

1 day ago


Fatih, Istanbul, Turkey Manpower Türkiye Full time

We are looking for a skilled Senior Regulatory Professional to join our team at Manpower Türkiye. The successful candidate will have extensive knowledge of regulatory agency regulations and interpretations.

About the Job:

  • 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 Responsibilities:

  • 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 role requires a Mid-Senior level professional with at least 6-8 years of experience.



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