Regulatory Intern

5 days ago

Bengaluru, India Eli Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
- Responsible to create tracking sheets for country affiliates to complete to reflect current CMC regulatory commitments. Responsible for resolving discrepancies with regulatory commitments for those individual markets, handling documentation confirming compliance, and monitoring assessment completion due dates
- Responsible to complete complex spreadsheets with metadata from current submission documents to ensure accurate document migration
- Responsible to create baseline submission content plans for global registrations and CMC post-approval submissions.
- Support the management of the RIM training database by maintaining realistic scenarios at the appropriate step of the process in order for trainees to execute training exercises effectively
- Support CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD
- Support the submission management process to ensure all required electronic records are timely, complete, and accurate. Track affiliate submission and market approvals.
- Comprehensive knowledge and skills related to Lilly systems, processes and standards
- Responsible to create tracking sheets for country affiliates to complete to reflect current CMC regulatory commitments. Responsible for resolving discrepancies with regulatory commitments for those individual markets, handling documentation confirming compliance, and monitoring assessment completion due dates
- Responsible to complete complex spreadsheets with metadata from current submission documents to ensure accurate document migration
- Responsible to create baseline submission content plans for global registrations and CMC post-approval submissions.
- Support the management of the RIM training database by maintaining realistic scenarios at the appropriate step of the process in order for trainees to execute training exercises effectively
- Support CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD
- Support the submission management process to ensure all required electronic records are timely, complete, and accurate. Track affiliate submission and market approvals.
- Comprehensive knowledge and skills related to Lilly systems, processes and standards

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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