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Are you a science graduate eager to make an impact in global regulatory affairs? Eli Lilly, a leading healthcare company, is hiring a Global CMC Regulatory Associate in Bangalore, India. This full-time role offers an opportunity to work at the forefront of CMC (Chemistry, Manufacturing, and Controls) regulatory submissions, ensuring safe and effective medicines reach patients worldwide.
Key Responsibilities
As a Global CMC Regulatory Associate at Lilly, you will:
- Lead the CMC submission management process, ensuring compliance with ICH CTD and global regulatory standards.
- Partner with CMC Regulatory Scientists to plan and prepare submission content for clinical studies and marketed products.
- Manage communication between Regional Submission Associates, GRA-CMC Scientists, RD&E Specialists, and Quality/Regulatory representatives.
- Ensure submission documentation aligns with local regulatory requirements and evolving electronic submission standards.
- Support lifecycle management, change control, and regulatory responses to global affiliates.
- Promote knowledge sharing, problem-solving, and collaboration across global teams.
Qualifications
To qualify for this role, candidates should have:
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- Bachelor’s or Masters degree in Pharmacy, Chemistry, or Life Sciences.
- Knowledge of pharmaceutical drug development and CMC regulatory affairs.
- Awareness of global agency submission procedures and electronic standards.
- Strong organizational, communication, and presentation skills.
- Ability to prioritize, solve problems, and collaborate across diverse teams.
Benefits of Working at Lilly
- Opportunity to work in a global healthcare leader.
- Exposure to international CMC regulatory frameworks.
- Professional growth in drug development and regulatory submissions.
- Inclusive workplace culture supporting diversity and equal opportunities.
How to Apply
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