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.
• Support internal and external audits by ensuring regulatory documentation and compliance files are accurate and audit ready.

Qualifications

• 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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