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Job role - CMC Regulatory AffairsExperience - 3-8 YearsLocation - BengaluruMode - HybridManage submissions• Plan submission workload by reviewing/monitoring RIM for planned documents forregistration submissions.• Partner with the Global Regulatory Associate and Regional Submission Associate toretrieve, publish, and submit• Modules 1-5 reports/documents and combine files into electronic submissions (eCTD)and/or non-eCTD submissions according to the master table of contents or ContentPlan for the dossier.• Coordinate global registration activities and provide the necessary documentation toaffiliates for registration of products in global countriesSubmit and archive submissions• Submit and archive submitted submissions, assuring all metadata fields are completein RIM.• Manage FDA Web trader account to enable submissions via electronic gateway.• Assure all appropriate metadata fields are completed when archiving in electronicfiling system (RIM).• Assure accurate entry for future retrieval of submissions if/when requestedBuild on high level of expertise in electronic publishing• Achieve a high level of technical and practical proficiency with eCTD XPress, Adobe• Acrobat, Submission Validation software (Lorenz), ISIToolbox.• Successfully complete the formal training modules.• Stay up to date on system and tool upgrades that impact publishing.• Share technical information among staff members and apply what is learned in dayto-day work.• Apply learning from quality review of submission work.• Keep up to date in subject matter expert area.Build technical and quality expertise• Understand changes to Regulatory Guidance and Requirements and advise RDE• Management as to their potential impact on Publishing.• Keep current on latest quality improvement methods.• Ensure best practices through partnership with Regulatory Quality