- Leading regulatory compliance team.- Preparing the strategy for regulatory filing within time frame.- Compilation, review, and submission of dossier for drugs product registration in US and Europemarkets.- Submission of response of queries received from Country’s Regulatory Agents and RegulatoryAgencies.- Review of plant documents like batch records, process validation protocols and reports etc.- Review the documents prepared by R&D like PDR, analytical
- Leading regulatory compliance team.- Preparing the strategy for regulatory filing within time frame.- Compilation, review, and submission of dossier for drugs product registration in US and Europemarkets.- Submission of response of queries received from Country’s Regulatory Agents and RegulatoryAgencies.- Review of plant documents like batch records, process validation protocols and reports etc.- Review the documents prepared by R&D like PDR, analytical