Regulatory Affairs Associate

• Review and compile Module 1 of the registration dossier in cooperation with the department head, the Regulatory Competence Centers (RCC) department and the local distributors to fulfil the local requirements and ensure smooth and rapid submission of the files, in a timely manner, in line with the registration planning cascaded by the department head.
• Prepare, review and release the artworks in coordination with the countries and the manufacturing site.
• Communicate the deficiency letters raised by the Health Authorities to the department head and RCC during evaluation within a specific timeframe.
• Ensure that launch pre-requisites in terms of MA approval, SKU creation, artworks and analysis requirements, as applicable per local regulations, are fulfilled timely according to agreed launch dates.