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Regulatory Affairs Executive
JOB_REQUIREMENTS
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Key Responsibilities
- Prepare accurate and timely responses to KDFCA (Kuwait Drug and Food Control Administration) inquiries in coordination with relevant departments, ensuring compliance with MOH Kuwait regulations and submission deadlines.
- Review and analyze variations received from internal departments, determine their classification, assess required documentation, and prepare variation submissions in accordance with KDFCA regulatory guidelines.
- Compile, validate, and submit CTD/eCTD dossiers for pharmaceuticals, medical devices, and health supplements as required by MOH Kuwait.
- Monitor and follow up on regulatory submissions, pricing applications, inquiries, renewals, variations, and product approvals to ensure smooth processing and timely outcomes.
- Support the execution of the product registration and re-registration plan by tracking progress and coordinating with internal stakeholders to achieve regulatory timelines.
- Maintain valid registration of all marketed products, ensuring that PILs, SmPCs, labels, and artworks are continuously updated and compliant with Kuwait regulations.
- Serve as the regulatory liaison for product life cycle activities, including post-approval changes, renewals, and regulatory updates to ensure uninterrupted product availability in the Kuwait market.
- Stay informed about updates in Kuwait’s regulatory environment and advise management on potential risks, impacts, or opportunities.
- Build and maintain strong relationships with KDFCA officials, MOH Kuwait representatives, and regulatory consultants to ensure smooth regulatory interactions.
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Support internal and external audits by ensuring regulatory documentation and compliance files are accurate and audit ready.
- Bachelor’s or master’s degree in pharmacy, Life Sciences, or a related discipline.
- Minimum 1–4 years of experience in Regulatory Affairs within the pharmaceutical or healthcare sector, preferably with experience in Kuwait or the GCC region.
- Strong understanding of KDFCA/MOH Kuwait submission processes, regulations, and requirements.
- Hands-on experience with CTD/eCTD dossier preparation and publishing.
- Proven experience in handling product registrations, variations, renewals, and other regulatory compliance activities.
- Prior experience in supervising or mentoring a small team is preferred.
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