• Prepare Submission Cover letters and forms per appropriate regional submission and route for appropriate review and
• Plan submission workload by reviewing/monitoring the RDE RIM or Share Point Calendar for planned documents for
• Partner with the Regulatory Associate to retrieve, publish, and submit Modules 1-5 reports/documents and combine
files into electronic submissions (eCTD) according to the master table of contents or Content Plan for the dossier.
o retrieve and publish CRFs and datasets required for regulatory submissions
o retrieve and publish literature references (bibliographies)
o retrieve, publish, and submit U.S. FDA required periodic reports
o retrieve, process, publish, and submit U.S. FDA required post-Marketing supplements and amendments
o ensure compliance with 30-Day Packet and Med Watch submissions.
o create different dossiers for Europe, the U.S., Canada, or other supported worldwide markets. Dossiers are
distributed to regulatory agencies and Lilly affiliate offices worldwide.
• Share knowledge, help train and educate others: about general submission knowledge including CRFs, datasets,
submission required literature references(bibliographies), periodic reports, post-Marketing supplements and
• Coordinate global registration activities and provide the necessary documentation to affiliates for registration of
products in global countries. Duties include preparing and/or expertise in requesting Indiana Free Sale Certificates,
FDA Certificates of Pharmaceutical Product (CPPs), MOH GMP Certificates, Price Certificates, Regulatory Status
Letters, and Letters of Clarification.
Submit and archive registrations
• Submit and archive submitted registrations, incoming correspondence, and Records of Contact with Regulators
assuring all metadata fields are complete in eFiles or RIM.
• Manage FDA Web trader account to enable submissions via electronic gateway.
• Assure all appropriate metadata fields are completed when archiving in electronic filing
system (eFiles or RIM).
• Assure accurate entry for future retrieval if/when requested.
Build 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 day-to-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.
Apply : https://lilly.wd5.myworkdayjobs.com/en-US/LLY/job/India-Bengaluru/Analyst_R-57901-2?source=linkedin&locationCountry=c4f78be1a8f14da0ab49ce1162348a5e&jobFamilyGroup=99c6e09d03e801a7d2687e7ff04aec33&jobFamilyGroup=99c6e09d03e801faaecc807ff04af433