Regulatory Affairs Officer
May 2014 - Present
Currently working in API regulatory affairs department.
Responsible for compilation and submission of DMF’s/amendments with USFDA, TPD-Canada, EMA-Europe, KFDA-Korea, TGA-Australia, PMDA-Japan and various ROW health authorities.
Submission of new CEP application and revision CEP dossier with EDQM.
Responsible for responding queries received from the USFDA, TPD, EDQM and ROW health authorities.
Responsible for responding queries from various customers with respect to their ANDA submission.
Experience in handling regulatory requirements through the product life cycle both in preapproval as well as post approval phases with core focus in CMC.
Review of various DMFs and various regulatory documents complied by team members.
Review of change proposals and technology transfer documents for any regulatory implication.
Preparation of Applicants part, Technical information files and issuance of various regulatory documents to the customers for ANDA fillings.
Co-ordination with QA, QC, R&D and supply chain department to collect the data for DMF’s compilation and submission.
Regulatory Affairs Executive
Responsible for compilation and submission of DMF’s/amendments with the regulatory authorities (viz., USFDA, TPD Canada, EU authorities, KFDA, TGA and PMDA).
Preparation of Technical information file and Applicants parts for various customers.
DMF’s submission in different ROW countries
Responsible for site registration in US and Japan health authority.
Responsible for responding queries to regulatory authorities and customer queries.
Co-ordination with QC/QA/R&D to collect the data for DMF’s compilation.
Lupin pharmaceuticals Co. Ltd., India
Experience in analytical research and development laboratory. Responsible for analytical method development in HPLC for monitoring the reactions, estimation of Assay, Related substances, genotoxic impurities and chiral purity. Validation of methods as per ICH guidelines. Part of technology transfer of various projects from R&D to manufacturing locations. Data compilation of various analytical results.
Name: National Environmental Engineering Research Institute
Project topic: Microbial and Chemical analysis of water(waste water).
Name: National Chemical Laboratory
Project topic: Determination of molecular weight of Amino acids by using MALDI-TOF technique.