Regulatory Affairs Executive @ Qualitron BioMedica

Regulatory Affairs Executive
Qualitron BioMedica Pvt Ltd - Mumbai, Maharashtra

Preparation of dossiers for different unregulated, semi-regulated markets of Pharma, Cosmetics and Food. Ensuring timely submission of Dossiers in totality as per the incumbent plan. Ensuring completion of all Registration processes as per country requirements ensuing into product registration. Creating Import Registration documents to be submitted to DCGI and FSSAI for the goods manufactured outside India. Co-ordinate with the cross functional departments for primary data documents, certificates and samples required for submission. Collate and review primary data received from different departments towards regulatory dossier compilation for the relevant markets. In coordination with manufacturers to obtain all the relevant licenses and certificates for drug products and manufacturing licenses perform registration renewals variations during the life cycles of products or dossiers filed in assigned markets. Study the nature of query generated by Drug /Food Authorities of country and answer them with supportive technical documents. Assist the other departments and providing guidance to the cross functional team members on Regulatory Affairs issues and update them with developments in the team.