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Regulatory Affairs Executive
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Key Responsibilities
- Prepare accurate and timely responses to MOPH (Ministry of Public Health – Qatar) inquiries in coordination with relevant departments, ensuring compliance with applicable regulations and submission deadlines.
- Review and analyze variations received from internal departments, determine their classification, assess required documents, and prepare variation submissions in line with MOPH regulatory guidelines.
- Compile, validate, and submit CTD/eCTD dossiers for medicinal products, medical devices, and health supplements as per Qatar MOPH requirements.
- Monitor and follow up on regulatory submissions, pricing applications, inquiries, renewals, and variation statuses with MOPH to ensure process continuity and timely approvals.
- Ensure successful execution of the product registration plan by tracking milestones and coordinating with internal stakeholders to achieve regulatory objectives.
- Maintain valid registration of all marketed products, ensuring that PILs, SmPCs, labels, and artworks are updated and compliant with Qatar regulations.
- Act as the regulatory liaison for product life cycle activities, including post-approval changes, renewals, and regulatory updates to support product continuity in the Qatar market.
- Stay updated on changes in Qatar’s regulatory framework and provide strategic input to management on potential regulatory risks, impacts, or opportunities.
- Develop and maintain strong working relationships with MOPH officials, regulatory consultants, and government representatives to facilitate smooth regulatory interactions.
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Support internal and external audits by ensuring full readiness of regulatory documentation and compliance records.
- Bachelor’s or master’s degree in pharmacy, Life Sciences, or a related field.
- Minimum 1–4 years of experience in Regulatory Affairs within the pharmaceutical or healthcare sector, preferably with experience in the Qatar market or GCC region.
- Strong knowledge of MOPH submission processes, regulations, and online portals used in Qatar.
- Hands-on experience with CTD/eCTD compilation and publishing.
- Proven track record in handling product registrations, variations, renewals, and regulatory compliance.
- Prior experience in leading or mentoring a small team is an advantage.
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