Sakshi Sharma

Associate-global Regulatory Affairs @Eli Lilly and Company

Cork, IE

Employee of the Month - September-2023• Performing regulatory activities on the assigned Primary molecule/product.• Perform document publishing activities (bookmarks & hyperlinks) on the assigned project/document in a timely and efficient manner.• Perform peer QC review and ensuring optimum quality/compliance of all document publishing activities.• Perform hypertext linking for the documents, also perform the quality checks on hypertext links and do the necessary modifications, when necessary.• Familiarity with pharmaceutical regulations• Publish documents by using relevant tools/software’s (Eg: ISI toolbox).• Timely metrics capture and management of the submission workload within Team.• Communication of resource issue to team manager.• Responsible for day-to-day work allocation, process flows and constantly endeavoring to be able to lead the team from the front. • Ensure all records and documents maintained as per organizational requirement.• Working for US market (MAA, BLA, IND, NDA, Amendments, RTQs, PSUR, PADER, PBRER, Annual report submissions)• Working on softwares like RIM and Lorenz Validator for publishing and validating report.• Manage, maintain and submit submissions using eCTDxpress and Veeva Vault RIM for US, Canada, Australia, EU and Swiss markets. • Additionally, I am also responsible for allocating resources to different projects. Keeping a tab on the Resource pool.• Responsible for creating, maintaining and updating the Publisher’s Notebook and ensure that it captures detailed process of publishing along with the validation errors and troubleshooting the same.