Job Description

Job Details for Executive Regulatory Affairs Compilation of DMF in eCTD format and submit to regulated and semi regulated markets. Review and co-ordinate with other cross functional teams for responding the queries raised by regulatory authorities to the submitted DMF within timeline. Review of post approval changes and technical requirements as per regulatory perspective for submission of Amendment/Variation to respective countries. Handling the marketing requests and respond to customer queries Review of Specifications and analytical related documents for submission purpose. Review of technical documents like Batch records, Process validation reports, analytical method validation reports etc. Assessment of change proposals from regulatory perspective. Regulatory compliance for assigned projects of advanced markets (USA, EU, Japan, Brazil, China) Preparation & Submission of Annual reports of USDMF products for all minor changes of Commercial and Exhibit products. Maintaining the database of post approval DMF Amendment/variation submissions and their approval status with implementation details. Maintaining log for Product History as per regulatory perspective. Good understanding of cGMP