BSc Chemistry Jobs at Lilly | Apply Now For The Global CMC Regulatory Associate Role
Lilly, a global healthcare leader, invites applications for the Global CMC Regulatory Associate position in Bangalore. This role is ideal for professionals with a scientific background in pharmacy, chemistry, or related fields, looking to advance their careers in global regulatory affairs and CMC submissions. The associate will support the registration, lifecycle maintenance, and regulatory compliance of pharmaceutical products worldwide.
- Job Position: Global CMC Regulatory Associate
- Location: Bangalore, Karnataka, India
- Job ID: R-92061
About the Company:
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. Committed to making life better, Lilly focuses on discovering, developing, and delivering life-changing medicines, while giving back to communities through philanthropy and volunteerism.
Job Description:
The Global CMC Regulatory Associate in Global Regulatory Affairs (GRA) – Regulatory Delivery & Excellence (RD&E) will manage operational and technical CMC registration processes, ensuring timely and compliant delivery of safe pharmaceutical products globally. The role involves coordinating submissions, maintaining the lifecycle, and communicating with internal teams, affiliates, and regulatory authorities.
Key Responsibilities:
- Lead CMC submission management processes and ensure compliance with global regulations (ICH CTD, electronic submission standards).
- Prepare submission content to support clinical studies, manufacturing changes, and marketed products.
- Triage affiliate inquiries, coordinate responses, and align with CMC RA Scientists.
- Partner with Regional Submission Associates to define strategies and timelines for deliverables.
- Implement and interpret global regulatory guidance and precedents for submissions.
- Facilitate discussions across CMC development teams to drive project decisions.
- Share regulatory and drug development expertise internally to meet product registration timelines.
- Communicate effectively across functions and geographies to influence decision-making.
Qualifications:
- Bachelor’s Degree in Pharmacy, Chemistry, or related scientific discipline.
- Knowledge of pharmaceutical drug development preferred.
- Awareness of agency submission procedures and emerging electronic standards.
- Strong written, verbal, and presentation skills.
- Ability to operate in a regulated environment with attention to detail.
- Strong teamwork, negotiation, and problem-solving skills.
Benefits:
- Opportunity to work in a leading global healthcare company.
- Exposure to global regulatory affairs, CMC submissions, and lifecycle management.
- Professional development and growth in cross-functional project management.
- Collaborative work environment with a focus on innovation and compliance.
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