Associate​/Sr. Associate​/Manager - Global Regulatory Affairs; GRA Regulatory Delivery

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.

The Global Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery and Excellence (RD&E), is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients around the world. This is accomplished through a strong working knowledge of regulations, guidances and regulatory precedence and collegial and mutually productive relationships across Lilly components, partner companies, and within relevant ministries of health.

The Associate utilizes process expertise and therapeutic area knowledge to drive appropriate internal consistency and influence effective change management within GRA and cross-functionally. The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application. It is expected that this position embraces corporate transformation initiatives and represents GRA as a change ambassador.

Provide Regulatory, Submission Planning and Execution Expertise

• Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content on a global and regional level. This includes but is not limited to all submission associates with INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD.
  
  This role may act to produce and submit eCTD submissions globally or regionally.
• Ensure incoming correspondence are archived accurately and related to appropriate records, assuring all metadata fields are complete in RIM.
• Partner with other geographies and Regional Submission Associates for non-eCTD countries to provide submission content in support of non-eCTD submissions in line with local agency regulations and requirements as needed. For example, utilize approved submission requirements provided in Regulatory systems to create submissions through the use of RIM technology allowing this role to lead the planning and execution for non-eCTD submissions and also drive any new electronic submissions in those regions who have and are adopting the eCTD specification.
• Support Affiliate Regulatory/Alliance Managers with RIM content planning for IND, MAA, Line extensions and new indication submission types.
• Create global and where appropriate regional content plans matching appropriate documents to support submission strategies defined by global regulatory strategy scientist or Regional/Affiliate Regulatory staff.
• Guide and influence development team and function regarding internal and Agency registration management processes and requirements.
• Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate. Records include IND and MAA submissions, tracking the status of pending applications and commitments, incoming correspondence, and records of contact
• Serve as the RD&E operational lead for registration planning and execution including but not limited to critical chain planning sessions and status updates, team operation meetings and RD&E planning.
• Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions).
• Partner with the Global Regulatory Strategy Scientist/Regional/Affiliate Regulatory Staff to drive the execution of product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process
• Provi…