Delivery Lead - Project Rose

• Assist in obtaining and maintaining government approval for drugs and cosmetics.• Compile and maintain regulatory documentation databases or systems.• Submitting requirements needed for re-registration phase and tentative to final registration phase of human pharmaceutical products.• Designing products’ insert and pack layout based on references such as FDA and EMC. • Submitting stability and bioequivalence files for newly registered products.

- Ensuring that all steps in the production process comply with Ministry of Health (MOH) regulations. - Submitting required documentation in the case of variations such as supplier, composition, physical, and delivering samples to be analysed in NODCAR.- Delivering raw materials to NODCAR to be analysed.-Submitting required documentation in the case of Comparative dissolution and Bioequivalence studies, and delivering the samples to be analysed in accredited centres.- Arranging meetings with Egyptian Drug Authority (EDA) inspectors.- Review batch records, Regulatory documents, Raw material invoices and Certificates of analysis.- Ensuring that the documentation meets EDA regulations.- Providing documentation to EDA inspectors in order to recieve release forms that allow raw materials to enter production.- Recieve release forms that allow finished goods into the market.- Responsible for managing narcotics stock and ensuring its compliance with EDA regulations.- Follow up with other sections such as Quality Assurance, Research and development and Supply Chain.

• Dispensing medicines, offering patients advice and practical help on medication compliance.• Advising patients of any adverse side-effects of medicines or potential interactions with othermedicines/ treatments.

• Revising patient’s medication sheets.• Consulting on chemotherapy dose and adverse effects.• Assessing the results of pharmaceutical treatments.

• Promoting and selling the company’s products• Consulting on chemotherapy dose and adverse effects.• Providing awareness to hospitals and pharmacies regarding new medical products.