Regional Regulatory Associate

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 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. 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 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. **Company Overview** Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: "Take what you find here and make it better and better." More than 140 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those who take our medicines, and extending to health care professionals, employees and the communities in which we live. We’ve received recognition from several distinguished organizations for our efforts. Here are some of our honors in recent years: - Catalyst Award, for our innovative Employee Journeys and People Strategy - Corporate Knights, Global 100 Most Sustainable Corporations in the World - Ethisphere, World's Most Ethical Companies 2019 - 3rd year in a row - Forbes, America's Best Employers for Diversity The purpose of the Regional Submission Associate, Global Regulatory Affairs (GRA) Regulatory Delivery and Excellence (RD&E) role is accountable for the operational and technical local and/or regional registration management processes that support the expedited delivery of safe and effective products to patients. - Manage country-specific submission requirements for assigned geographic area and contribute local Module 1 documents to RIM content plans for new MAAs, Line extensions and new indications - Monitor, manage and execute country post approval submission plan (i.e., CMC variations, product license renewals) by providing a submission ready dossier to affiliate regulatory or external alliance partner and performing related system updates & maintenance. - Serve as the Subject Matter Expert (SME) for global regulatory business processes and how those are executed in the Veeva Vault RIM system to ensure consistency of process execution and data. - Support affiliate regulatory and alliance partnerships with submission management. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. **Provide Regulatory, Submission Planning and Execution Expertise** - Create local Module 1 documents in RIM and manage reviews/approvals with affiliate staff - Prepare Submission Cover letters and forms per appropriate regional submission and route for appropriate review and approval - For eCTD countries: Collaborate with Global Regulatory associate to match local Module 1 documents to the Global content plan - For non-eCTD countries: Match appropriate documents to the local RIM content plan, send content plan for review and when review complete, lock & confirm the top-level content plan. - Coordinate with affiliate and regional regulatory leaders to align on “next-best submission date” in case of inability to meet Accelerate Reach and Scale goal - Ensure local activities to enable submission are completed (e.g. fee payment, MoH appointment etc) - Manage planning and tracking submission-level data in RIM for the affiliate and ensure RIM data is correct for Right-to-Operate submissions - Conduct impact assessment of local regulation changes and manage submission requirements and templates for assigned countries in central systems (e.g. R-Cubed/RIM templates) - Collaborate within Regional Submission Associate team to identify opportunities for harmonisation of requirements, challenge affiliate on dossier requirements when they stand in the way for harmonisation/globalisation and work closely with reg