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DRA Senior Associate, Gulf
Cairo, Egypt
Job Description
- 3 years’ experience in the regulatory field (new submission/ maintenance activity/ pricing) in assigned market(s).
- Review and compile the registration dossier in cooperation with the Regulatory Competence Centre (RCC) department and the local relevant stakeholders to fulfil the local requirements and ensure smooth and rapid submission and approval of the files, in a timely manner, in line with the registration planning cascaded by the line manager and DRA Head.
- Review and Validation of the promotional and educational materials against health authority regulations and approved product information and obtaining the authority approvals when applicable.
- Communicate the deficiency letters raised by the health authorities to line manager and DRA Head and relevant global stakeholders during evaluation within the specified timeframe.
- Ensure supply continuity of the registered products by securing the timely submissions and approvals of the variations and requesting special importation permit from HA when needed.
- Maintain all market artworks in coordination with the labeling responsible and manufacturing site in alignment with the country regulations and approved product information.
- Ensure execution of Pharmacovigilance and patient safety regulatory activities in compliance with the relevant SOPs and local HA regulations.
- Ensure that product patient information leaflets are updated according to the latest CDS update approved in the country of origin by securing timely submission in alignment with the relevant SOP.
- Complete and regular archiving the registration files, authorities correspondence and relevant documents.
- Monthly reporting of the activity, regular and accurate updating of the tracking tools.
- Regulatory intelligence database update with close follow up of the latest circulars and guidelines issued by the health authorities, and immediate gap assessment and timely implementation within the company when applicable.
- Contribution in overall strategy building, planning and execution of market activities to achieve the overall market(s) TGT and objectives.
- Support in onboarding and guidance of any new joiners in GLS DRA team.
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