Regulatory Affairs Executive

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