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

Role Summary

Global Regulatory Associate in GRA Regulatory Delivery & Excellence (RD&E) at Lilly is responsible for operational and technical registration management to support the expedited delivery of safe and effective medicines worldwide. Working knowledge of regulations, guidances, and regulatory precedence, plus cross-functional collaboration across Lilly and partner organizations, drives internal consistency and change management within GRA. The scope covers records from the start of clinical trials through the withdrawal of the marketing application and the role acts as a change ambassador during corporate transformation initiatives.

Based in Indianapolis, Indiana.

• Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content on a global and regional level, for INDs, NDAs, BLAs, NDSs, and other eCTD MAAs; ensure compliance with regulations and internal quality systems with a focus on delivering the development portfolio across all CTD modules; may produce and submit eCTD submissions globally or regionally.
• Ensure incoming correspondence is archived accurately and linked to appropriate records, with complete metadata in RIM.
• Partner with other geographies and Regional Submission Associates for non-eCTD countries to provide submission content for non-eCTD submissions in line with local requirements; utilize approved submission requirements in Regulatory systems to create submissions via RIM and lead planning and execution for non-eCTD submissions in regions 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 regional content plans to support submission strategies defined by global regulatory strategy scientists or regional/affiliate regulatory staff.
• Guide and influence development teams regarding internal and agency registration management processes and requirements.
• Own the registration management process at the molecule/project level to ensure all 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.
• Provide registration management expertise to the due diligence and business development processes.
• Serve as the registration management expert for other processes dependent upon the registration record (e.g. OSI requests, out-license, user fees/drug listing/orange book).
• Partner with Regulatory Policy to identify areas of desired change in the external environment.
• Take advantage of evolving technology and regulatory requirements to identify and seek opportunities for novel submission processes (e.g., cloud-based submissions).
• Develop collaborative relationships with personnel in other Lilly functional areas to effectively influence the electronic registration plan.
• Create an environment within the team and GRA that encourages open discussions on issues to achieve robust outcomes on project decisions and constructively challenge to reach the best solutions.
• As directed by leadership, develop collegial, mutually productive relationships with the FDA Office of Business Informatics (OBI) and applicable regulators in other countries to ensure understanding of the Agency's internal process and requirements to optimize the application presentation to facilitate review.
• Partner with the Affiliate/Regional Regulatory Staff to plan, facilitate and document internal, regulator, and partner meetings.
• Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise.
• Influence others in a manner that creates maximum advantage for the organization.
• Communicate verbally and in writing to effectively influence within work group/function and with development team.
• Serve as a mentor within GRA and SME for RD&E processes.

• Required:
  
  BS in a technical or scientific discipline (such as chemistry, biology, pharmacy).
• Required:
  
  2+ years of experience with the drug development process.
• Required:
  
  Authorized to work in the United States on a full-time basis;
  Lilly will not sponsor work authorization or visas for this role.
• Preferred:
  Quick learning agility, retention of knowledge, strong project management skills, flexibility, organizational skills, and fast…