alaa fakeha

* Regulatory & Quality Affairs Associate, covering FMCG/FMCH which include: * Pharmaceutical products. * Health products. * Cosmetics products. * Medical Devices. * Foods products. The main projects I am working on beside the daily duties: * Direct contact with SFDA (Drug, Medical Device and Food) sectors to solve any issues. * Renewal project, submission and follow up. * Variation (PIL update), submission and follow up. * Direct contact with the Global Regulatory team to collect the SFDA inquiries. * Pack management (Review and Approve). * Advertising Materials submission. * Fully compliance with the internal Regulatory systems. * Support the supply chain department on ground. * Medical Devices registration and MDMA certificate. * Registration Cosmetics products in eCosma system. * Registration Foods. * Creating Standard Operation Procedure (SOPs), from scratch. * L1 inspection and CAPA management.

* Responsibilities & Accountabilities :- * Product (Medical Devices & Pharmaceuticals) Registration in Saudi & Bahrain markets. * Vigilance: Post-Marketing Surveillance and Pharmacovigilance (PV). * Local/Lebal Packaging Review and Approval. * Management of Regulatory Databases, Systems, Submission Data, etc.. * RA Communication with SBU RA, Local Commercial and Sales teams, SFDA and governments 3rd parties, dealers and distributors. * Quality Orders and Standard Operating Procedures (SOP).

* Regulatory Affairs Coordinator, covering FMCG/FMCH which include: * Pharmaceutical products. * Health products. * Cosmetics products. * Medical Devices. * Foods products.

* Medical Representative: * Promotion Respiratory products. * Follow up the sales operation from A to Z. * Build and Growing the business through push the sales. * Coverage MOI centers in Riyadh and remote area. * Coverage Private polyclinics, Institution sectore and MOH Primary care centers.