Are you looking to build your career in pharmaceutical regulatory affairs with a global leader in healthcare? Lilly, one of the world’s most respected pharmaceutical companies, is hiring a Global CMC Regulatory Associate for its Bangalore, Karnataka office.
This full-time opportunity is ideal for professionals seeking to contribute to drug development, regulatory compliance, and lifecycle management in a dynamic and innovative environment.
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About Lilly
At Eli Lilly and Company, we unite caring with discovery to improve lives worldwide. Headquartered in Indianapolis, Indiana, Lilly is a global healthcare leader focused on developing and delivering life-changing medicines.
Through innovation, collaboration, and dedication, we aim to make healthcare more accessible and impactful for patients everywhere.
👉 Learn more about the company: Lilly Careers
Job Purpose
The Global CMC Regulatory Associate within the Global Regulatory Affairs (GRA) – Regulatory Delivery and Excellence (RD&E) team is responsible for managing CMC registration processes. This role ensures timely delivery of safe and effective products to patients worldwide through regulatory expertise, process management, and cross-functional collaboration.
The associate will work on CMC submissions, lifecycle maintenance, change management, and regulatory strategy development across different regions and product stages — from clinical trials to marketed products.
Key Responsibilities
Regulatory & Drug Development Expertise
- Lead CMC submission management processes and ensure compliance with ICH CTD and global agency standards.
- Partner with CMC RA Scientists to prepare and plan submission content for clinical studies and manufacturing changes.
- Manage responses to affiliate inquiries and regulatory questions.
- Implement and interpret global regulatory requirements, precedents, and publishing standards.
- Align with Regional Submission Associates on submission timelines and strategies.
Collaboration & Leadership
- Foster open discussions within teams to reach robust regulatory decisions.
- Share expertise through internal forums to drive regulatory and drug development excellence.
- Communicate effectively across functions and geographies to support lifecycle management processes.
- Demonstrate problem-solving and decision-making skills to influence regulatory strategies.
Minimum Qualifications
- Bachelor’s Degree in Pharmacy, Chemistry, or a related scientific discipline.
- Knowledge of pharmaceutical drug development or industry-related experience.
Preferred Skills & Experience
- Familiarity with agency submission procedures and electronic submission standards.
- Strong attention to detail and ability to manage regulatory operations in a compliance-driven environment.
- Excellent communication, presentation, and negotiation skills.
- Effective team player with proven ability to work across diverse functions.
Job Details
- Job Title: Global CMC Regulatory Associate
- Location: Bangalore, Karnataka, India
- Category: Research & Development
- Job Type: Full Time (Regular)
- Job ID: R-92061
Verified Job
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Diversity & Inclusion at Lilly
Lilly is an equal opportunity employer committed to diversity, equity, and inclusion. We provide reasonable accommodations for individuals with disabilities to actively engage in the workforce.
📍 Workplace accommodation requests can be submitted here: Lilly Workplace Accommodation
We do not discriminate based on age, race, religion, gender, sexual orientation, gender identity, national origin, veteran status, or disability.
Why Join Lilly?
- Be part of a global pharmaceutical leader.
- Contribute to the development of innovative medicines that improve lives.
- Work in a collaborative, inclusive, and growth-driven environment.
- Build a career in regulatory affairs and drug development with global exposure.