Tarun Gill

Specialist @Eli Lilly and Company

Bengaluru, IN

Involved in CMC team Global Submission Strategy- Contribute to global submission planning and execution for CTD Module 1 and regional sections- Support marketing authorization transfers, site renewals, variations, and tender bids- Coordinate registration activities by preparing and requesting essential documents: Content Plan Management- Ensure timely and accurate updates to submission content plans- Lock and confirm modules (especially Modules 1, and 3)- Remove outdated documents and map approved ones- Manage document revisions and metadata in Veeva vault RIM systems- Adhere to document naming conventions, classification standards, revision tracking, and reason for revision documentation. Knowledge & Expertise- Demonstrate deep understanding of CTD structure, especially Module 1- Maintain familiarity with regional regulatory requirements and document classifications- Prioritize submissions based on due dates and ensure timely delivery. Communication & Documentation- Respond to affiliate inquiries and provide document support- Maintain clear records of actions and document status- Monitor the CMC Submission mailbox and act promptly on assigned projects- Provide support for regulatory documents related to new registrations and renewals in Emerging Markets and ROWs🧠 Process Improvement & Strategic SupportParticipate in process improvement initiatives for team such as process automations in RIMs for which I have received Lilly innovator and Quality Pinnacle award-Saves manual effort and prevents delays-Improves compliance and submission quality-Impacts over 100 stakeholders across publishing and affiliate teams. 🤝 Cross-Functional Collaboration- Work closely with: CMC RA Scientists, Regional Submission Associates, Publishing Teams, RA to align on submission timelines and resolve document gaps- Participate in team meeting to discuss challenges, workload, and best practices.