Regulatory Compliance Specialist

19 hours ago


Fatih, Istanbul, Turkey Manpower Türkiye Full time

We are seeking a Senior Regulatory Specialist to join our team at Manpower Türkiye. This role is ideal for an experienced professional with a strong background in regulatory affairs.

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 solutions to complex problems requiring data analysis and evaluation of intangible variables.
  • Offer regulatory advice to project teams and organize reporting schedules for new drug/medical device applications and renewals.
  • Conduct global regulatory impact assessments for changes at manufacturing sites and ensure submission of relevant changes.
  • Review and approve text drafts and artworks of labels, packaging, and instructions for use.
  • Support Regulatory Affairs during audits.

Key Qualifications:

  • Minimum 6-8 years of experience

Job Type: Full-time



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