Regulatory Affairs Specialist
Current Preparation and submission of Registration dossiers/Marketing authorization application(MAA) for the drug registration with proposed samples of range of drug products to the ministries of health in various African countries like Mozambique,Cameroon,Zambia,Mali,Kenya,Sierra Leone,Congo RDC,Malawi,Burkina Faso,Combodia,Ethiopia,Madagascar,Mauritania,Uganda,Niger, Tchad, Kenya, Tanzania, Zimbabwe etc.We handle the queries arises after submission of the marketing authorization application from respective ministries of health and respond to the queries sufficiently resulting in successful registration of drug in respective countries. I prepare and approve Patient Information Leaflets (PILs) for range of products. I am responsible to approve the product labels and layouts for respective drug products. Renewal of Registration of Drug products which are already registered. We plan the before strategy for drug registration where we receive the forecast from sales department. Provides leadership and management of Regulatory Affairs and Adverse Effect reporting. Understands and supports the directions taken in the areas of GMP compliance. Directs regulatory strategies and submissions for applicable projects. Identifies and assesses regulatory and quality risks associated with projects - defines strategies to mitigate risk. Supports and trains current and incoming department personnel to operate critical functions of the company’s Regulatory Affairs. Identifies and assesses regulatory and quality risks associated with projects - defines strategies to mitigate risk. Supports and trains current and incoming department personnel to operate critical functions of the company’s Regulatory Affairs.
