Associate​/Sr. Associate​/Manager - Global CMC Regulatory, Regulatory Delivery and Excellence

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery and Excellence (RD&E) is accountable for the operational and technical CMC 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 related to CMC, guidance’s, and CMC regulatory precedence and collegial and mutually productive relationships across Lilly components, and partner companies.

The Global CMC Regulatory Associate utilizes CMC process expertise and CMC product specific knowledge to drive appropriate internal consistency and influence effective change management within GRA and cross‑functionally. The scope of the work includes CMC records from the start of clinical trials through withdrawal of the marketing application.

The Associate/Sr. Associate/Manager works within regulations to expedite the registration and lifecycle maintenance of products. They will prioritize and manage the communications between our Regional Submission Associates, GRA‑CMC Scientists, RD&E Specialists, and the Quality/Reg Representatives. The Associate utilizes CMC submission process expertise and expertise with Information Technology tools to develop project management expectations across projects. Based on implementation and supply chain needs within manufacturing, the Associate will be responsible for routine communication of submission tracking requirements to both GRA‑CMC Scientists and internal customers.

The scope of work includes global regulatory requirement assessment and strategy development, coordination of submissions with the RD&E specialists, and project management for marketed product support.

It is encouraged that this position embraces corporate transformation initiatives and represents GRA as a change ambassador.

• Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including an extensive knowledge of ICH CTD and evolving global agency standards, CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
• Partner with the GRA‑CMC Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
• Partner with the GRA‑CMC Scientist to drive the execution of submission planning for global registration and maintenance submissions.
• Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with GRA‑CMC Scientist for guidance in effort to prepare responses to questions.
• Implement and in some cases interpret global regulations and guidance’s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Regional Submission Associate, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.
• Partner with Regional Submission Associate to align on submission strategies and timeline for deliverables and manage communications between Regional Submission Associate, GRA‑CMC…