
Regulatory Compliance Specialist
19 hours ago
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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