API Regulatory Affairs - DMF Filing

Role Overview: As an Associate Manager / Manager in API Regulatory Affairs - DMF Filing/ Compilation for the global market, your responsibilities will include: - Hands-on experience in Regulatory Affairs-API/DMF Filing/DMF Compilation/ Submission/ Customer Communication. - Compiling and submitting DMFs globally for small molecule APIs in eCTD format, ensuring compliance with ICH and region-specific regulatory guidelines (EU, US, Canada, Japan, Australia, Brazil, China, South Korea, etc.). - Demonstrating good knowledge of all regulatory guidelines and API Regulatory processes. - Compiling responses to queries from Regulatory Agencies & customers globally, meeting specified timelines for submission. - Reviewing and submitting new DMFs, deficiency responses, amendments, and updates to various regulatory agencies. - Evaluating change controls and updating agencies by considering change categories. - Having hands-on experience in eCTD software. Qualification Required: - M.Sc. / M.Pharma degree. - Experience in Regulatory Affairs ranging from 11 to 18 years. Additional Details: If you possess the relevant experience for this role, please share your CV with rashmi.gupta@biocon.com including the following details: - Total Experience - Current CTC - Total number of DMF filings - Major markets handled globally - Notice Period - Willingness to work in Bangalore (onsite) for a 5-day work week.,