API RA Role in Mumbai

The main purpose of the role of Team Member CDT Regulatory Affairs - AP I at CIPLA R & D is to compile dossiers in accordance with regulatory strategy, manage deficiencies, evaluate products, and submit tenders to ensure adherence to regulatory requirements for various regulated/international markets within agreed timelines. As a Team Member CDT Regulatory Affairs - AP I, your responsibilities will include reviewing documents, compiling and submitting quality dossiers in line with regulatory guidelines for various regulated/international markets to minimize deficiencies from health authorities. You will also be required to evaluate and compile quality deficiency responses for all regions to meet targeted timelines set by health authorities and customers. In this role, you will need to assess and submit product evaluations and tender documents to regional teams for DRF conversion and product commercialization. Additionally, you will be responsible for staying updated on new regulatory guidelines through ongoing training and interactions with regional teams to minimize deficiencies effectively. To be considered for this position, you should hold a graduate or post-graduate degree in Pharmacy and possess at least 5 years of relevant experience in the field of Regulatory Affairs or Quality Assurance. This position is based in Vikhroli, Mumbai.,