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.

Accountable for GSC regulatory writing and study submission/approval capabilities.
• Carefully studies and develops/maintains expertise on regulatory writing technique and skills, study
submission/approval setting, including monitoring guidance, advisory committees and other regulatory approval forums, as well as other pharmaceutical company’s submissions/approvals.




• Uses external and internal insights to identify emerging trends and requirements and to inform, develop, and refine
GSC and Lilly regulatory writing, content and study submission strategies
• Responsible for global onboarding/training programming for design and study development and provides leadership
in implementation
• Develops close, cross-functional relationships with clinical development experts within Lilly. Collaborates and
advises asset teams on study design, strategy, planning, execution, and best practices for critical study-related work, including incorporation of requirements.
• Serves as Subject Matter Expert within and outside of GSC on core business processes, procedures and applicable
documents
• Process Owner for applicable regulatory writing and study processes
• Responsible for leading/managing functional initiatives
• May represent GSC in due diligence activities
Leads GSC design and study capability excellence:
• Serves as GSC representati

📌 Regulatory Writing Capability Lead Bengaluru
🏢 Eli Lilly Services India
📍 Bengaluru