Active coordination of the preparation and submission of the registration files in a timely manner, in line with the registration planning and ME management instruction
Review and compile the M1 in cooperation with the RCC department and the local distributors to fulfil the local requirements and ensure smooth and rapid submission of the files.
Prepare, review and release the artworks in coordination with the countries and the manufacturing site
Review and Validation of the promotional material and regulatory support for the compliance committee.
Co-ordinate and respond to requests by the authorities during the evaluation process, and check the correct handling of deficiency letters within a specific timeframe ( 15 to 45 days Max)
Follow up the maintenance of the registered products (Renewal/variation) in coordination with the LCM (Life cycle maintenance) department and the supply chain department in order to ensure smooth supply and stock management.
The incumbent will also complete and regular archiving the registration files and related documents
Close follow up and monitoring of the regulatory activity with the local distributors ( Bi-weekly / or monthly meeting)
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 from the MoH, and immediate implementation within the company
Improve and encourage the compliance practices related to the DRA activity and Sandoz business
Regulatory Support for the local business development activity: Local packaging/ licensing/local manufacturing) Regulatory support for the tender business
Qualifications, Skills and Experience:
The applicant must hold a University Degree in Science English and Arabic
Two to three years experience in the regulatory field ( new submission/ maintenance activity/ tender/ pricing) in the Gulf countries.
Novartis International AG is a Swiss multinational pharmaceutical company based in Basel, Switzerland. It is one of the largest pharmaceutical companies by both market cap and sales. Novartis manufactures the drugs clozapine (Clozaril), diclofenac (Voltaren), carbamazepine (Tegretol), valsartan (Diovan), imatinib mesylate (Gleevec/Glivec), ciclosporin (Neoral/Sandimmun), letrozole (Femara), methylphenidate (Ritalin), terbinafine (Lamisil), and others.