Regulatory Compliance Expert

1 day ago


Fatih, Istanbul, Turkey Manpower Türkiye Full time

We are seeking a highly experienced Regulatory Compliance Expert to join our team at Manpower Türkiye. As a Senior Regulatory Specialist, you will be responsible for ensuring compliance with regulatory agency regulations and interpretations.

About the Role:

  • Prepares responses to regulatory agencies' questions and other correspondence.
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines including upload of regulatory relevant information to the UTS database or to other authorities.
  • Develops timelines for submissions under the direction of senior regulatory affairs staff.

Responsibilities:

  • Ensures compliance with regulatory agency regulations and interpretations.
  • Prepares responses to regulatory agencies' questions and other correspondence.
  • Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines including upload of regulatory relevant information to the UTS database or to other authorities.
  • Develops timelines for submissions under the direction of senior regulatory affairs staff.
  • Provides solutions to complex problems in which data analysis requires an evaluation of intangible variables.
  • Provides regulatory advice to project teams. Organizes and maintains reporting schedules for new drug / new medical device application and renewals.
  • Global Regulatory impact assessments for all changes at the manufacturing sites and ensuring submission of relevant changes if needed.
  • Review (in view of compliance with regulatory requirements) 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.
  • Supporting the Regulatory Affairs part of audits.

Requirements:

  • Min 6-8 years of experience

This is a Mid-Senior level position that requires full-time commitment.



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