Regulatory Associate Jobs at Lilly | BSc Chemistry Candidates Apply Now
Are you looking for an exciting career in global regulatory affairs with one of the world’s leading pharmaceutical companies? Eli Lilly and Company is hiring a Global CMC Regulatory Associate in Bangalore, Karnataka, India. This full-time opportunity is ideal for candidates passionate about regulatory operations, drug development, and CMC submission management. Join Lilly’s mission to unite caring with discovery and make life better for people everywhere.
About Lilly
At Lilly, we unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, we are a global healthcare leader with employees dedicated to discovering, developing, and delivering life-changing medicines. Our commitment goes beyond research — we focus on improving disease management, giving back to communities, and putting people first.
Job Details
- Job Opening: Global CMC Regulatory Associate
- Location: Bangalore, Karnataka, India
- Category: Research & Development
- Job Type: Full Time, Regular
- Job ID: R-92061
Minimum Qualification Requirements
- Bachelor’s degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related field).
- Knowledge of pharmaceutical drug development or industry-related experience preferred.
Purpose of the Role
The Global CMC Regulatory Associate in Global Regulatory Affairs (GRA) – Regulatory Delivery and Excellence (RD&E) is accountable for operational and technical CMC registration management. The role supports expedited delivery of safe and effective products to patients worldwide through a strong knowledge of CMC regulations, guidance, and regulatory precedence. This position involves working across Lilly components and partner companies, managing CMC records from the start of clinical trials through withdrawal of marketing applications, and supporting lifecycle product maintenance.
Primary Responsibilities
Regulatory & Drug Development Expertise
- Lead CMC submission management by providing knowledge of global regulatory requirements (ICH CTD and agency standards).
- Prepare CMC CTD content aligned with manufacturing changes and technical reports.
- Partner with CMC RA Scientists to plan and execute submission content for clinical studies and marketed products.
- Triage and respond to affiliate inquiries with CMC RA Scientist guidance.
- Interpret global regulations and implement submission standards.
- Collaborate with Regional Submission Associates on strategies, timelines, and submission standards.
Lead, Influence, Partner
- Create an environment encouraging open discussions for robust project decisions.
- Share expertise on regulatory and drug development to meet product registration timelines.
- Guide and influence teams on lifecycle management processes.
- Demonstrate problem-solving skills and effective cross-functional communication.
Additional Preferences
- Experience with drug development processes.
- Knowledge of agency submission procedures and emerging electronic standards.
- Strong written, spoken, and presentation skills.
- Ability to prioritize, negotiate, and work in regulated environments.
- Effective teamwork and adaptability in diverse environments.
Equal Opportunity Employer
Lilly is committed to equal opportunities for all, including individuals with disabilities. We ensure an inclusive workplace where every individual is respected and valued.
Keywords: Global CMC Regulatory Associate, Lilly Bangalore jobs, Latest BSc Chemistry Jobs at Lilly, Regulatory Affairs jobs India, Pharmaceutical regulatory careers, Pharma Jobs, Drug development
