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.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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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