Regulatory Affairs Specialist
EGMED -
Sheraton, CairoPosted 4 years ago150Applicants for1 open position
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- 14In Consideration
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Job Description
- Prepare needed documents by keeping necessary documentation obtained from suppliers through direct supervisor and organizing registration file that includes contracts, and certificates needed for registration file S14, Conformity European for QA (CE), Free Sales Certificate (FSC), and Food and Drug Administration certificate (FDA) to facilitate submission to MOH Administration.
- Early planning and implementation of new product registration procedure.
- Obtaining early regulatory approval of new products and early renewal for old registered products by daily follow up with MOH responsible persons to fulfill any requirements needed to finish the registration / re-registration procedures.
- Acts as a contact person for MOH personnel & the suppliers.
- Handle registration coordination through keeping Registration Licenses (RL) updated and communicated with MOH Administration to maintain products registered.
- Coordinate with MOH Inspectors , EG supply chain and warehouse teams to ensure fast MOH withdrawal and final / partial release of the Pharmaceutical products, Medical Devices and Diagnostics by preparing all necessary documentation &
- managing all the process till the final release.
- Follow up with NODCAR , NORCB , Nutrition Institute and MOH central Lab by preparing all the necessary documents, Reference Standard and Chemicals to ensure fast analysis approval of the withdrawn samples.
- Follow up the validity of documentations through report the direct manager with the expiry status for contracts, S14, Conformity European for QA (CE), Free Sales Certificate (FSC), and Food and Drug Administration certificate (FDA) in order to keep management informed and take action if needed.
- Ensure Regulatory compliance of approved products ( price, shelf life , pack, manufacturing sites, codes,….).
- Warehouse & Factories licensing : submission of documents to MOH for updating the current licenses and getting licenses for new warehouses.
- Preparing & submission of the Pharmaceutical Products annual import plan files according to sales plan.
- Liaise between MOH authorities and the company through coordinating meetings and contacting responsible employees in the MOH Administration to ensure effective communication between both parties.
- Confirm registration through Informing Order Processing Department with the registration status of different Pharmaceutical Products / Medical Devices to avoid having any obstacles in customs clearance process.
- Coordinate the flow of original documents by working as a liaison between customs department and different Business Units to ensure proper circulation of documents.
- Report direct supervisor with registration process through submitting monthly registration status report, as well as any issues or problems that may occur in order to keep management informed and take action if needed.
- Performing administrative activities-performing day to day administrative tests such as maintains files & processing paper work
- Preparing all the necessary documents needed for the import file to be submitted to MOH and monitor it till final MOH import approval.
- Deputy PVRP (Deputy Pharmacovigilance Responsible Person).
Job Requirements
- Pharmacy graduate is a must
- Preferable 2 years experience in the same field
- Excellent communication and negotiation skills.
