Regulatory Affairs Specialist
Novo Nordisk Gulf Cluster
Total years of experience :8 years, 0 Months
-New registrations, Variations and Renewal files preparation, coordination with agents for files submission and approvals.
-Obtain and maintain marketing authorizations to all Novo Nordisk products.
-Maintain packaging material and labelling up-to-date according to HQ / local authorities’ requests.
-Submission of safety data.
-Approval of promotional materials
-Registration for new products
-Renewal of existing products
-maintaining registered products (product's variation file submission)
-Maintaining PV system
-handling the communication with the principals
-Coordination of tender reviews and deadlines and adjust them to the frameworks given by the customers
-Contribution in cost and price calculations
Coordinating the approval and registration of pharmaceuticals, veterinary medicines, complementary medicines, agrochemicals, pesticides, therapeutic devices, cosmetics and other products(crucial link between our company, its products and regulatory authorities of the country) as i handle
* Collecting and evaluating scientific data that is required by
MOH Kuwait to release a medicine for sale.
* Preparing submissions of license variations and renewals to strict deadlines.
* Ensuring proper records are kept by appropriate staff in Warehouse
on restricted medicines per QC dept. requirement.
* Process MOH/QC release of items imported for sale.
*Specifying storage, labeling and packaging requirements to the
warehouse in charge.
- Learning how to sell and present infront of the customers.
- Learning about the overall environment from the seller point of view.
- Learning more about medicines and the devices that are available in the pharmacy.
did an internship for 400 hours (2009-2012) at Naser Elias Pharmacy ,Deir Ateye, Syria