Regulatory Affairs Officer
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.