Work as Global CMC Regulatory Associate at Lilly

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.

Post : Global CMC Regulatory Associate

Job Description
Regulatory & Drug Development Expertise
• Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive 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 CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
• Partner with the CMC RA 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 CMC RA 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 scientists, RD&E specialists and Quality/Regulatory representatives.
Lead, Influence, Partner
• Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.
• Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.
• Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes
• Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies

Candidate Profile
• Bachelor’s Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline)
• Knowledge of pharmaceutical drug development or industry-related experience preferred.
Other Information/Additional Preferences:
• Drug development process or Industry-related experience
• Knowledge of Agency submission procedures and practices. Knowledge / awareness of emerging submission electronic standards.
• Ability to operate and manage operational requirements in a regulated environment
• Written, spoken and presentation skills
• Negotiation and influence skills
• Attention to detail and ability to effectively prioritize
• Proven effective teamwork skills; able to adapt to diverse interpersonal styles

Additional Information
Qualification : Bachelor’s Degree
Location : Bangalore, Karnataka
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R-92061
End Date : 30th September 2025