Regulatory Affairs Officer

• Responsible for overseeing regulatory compliance and ensuring the effective distribution of pharmaceutical products in accordance with regulatory guidelines and standards.

Registration Activities

1. Governance of the Kuwait regulatory landscape and requirements for local registration: preparing, submitting and negotiating with regional regulatory bodies to obtain approval or clearance of premarket registration as well as post market compliance
2. Provides expertise in translating regulatory requirements into practice, workable plans
3. Collaborate with the regional regulatory team and local regulatory lead to ensure compliance to local market regulations and technical file submissions
4. Collaborate with Product Managers and Marketing teams: Assures timely regulatory clearances and registrations for new product launches, renewals to ensure timely market access, continuous product availability and compliance
5. Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements
6. Compiles all materials required in submissions, license renewal and annual registrations
7. Identifies the regulatory impact : changes of labelling, manufacturing, marketing for regulatory compliance, submitting the required change notifications
8. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes
9. Directing interactions with regulatory agencies on defined matters, working with advocacy principles to ensure rapid and optimal registration for new products and indications, as well as line extensions and ensuring the effective and compliant regulatory maintenance of existing products.
10. . To support audit activities, ensuring compliance to the divisional requirements