Join Eli Lilly and Company, a global healthcare leader, as a Manager / Senior Manager – Regulatory Affairs in Gurgaon, Haryana. Drive regulatory strategies to bring life-changing medicines to patients worldwide.
About Eli Lilly and Company
Lilly, headquartered in Indianapolis, unites caring with discovery to improve lives. Operating in India since 1993, our Gurgaon hub drives treatments in cardiometabolic health, oncology, and immunology. Learn more at Lilly India Careers.
Position Overview
The Manager / Senior Manager – Regulatory Affairs oversees regulatory operations, ensuring compliance and successful product registrations. This role collaborates with cross-functional teams and regulatory authorities to support Lilly’s mission in India.
Key Responsibilities
Regulatory Plan Execution
- Implement regulatory plans aligned with business and compliance goals.
- Prepare and submit high-quality applications for marketing authorizations.
- Maintain licenses through timely renewals, variations, and periodic reports.
- Represent regulatory affairs in affiliate lead team discussions.
Regulatory Compliance
- Ensure internal IT tools and regulatory archives are accurate and up-to-date.
- Support audits and implement corrective/preventive actions.
- Oversee third-party regulatory service providers (e.g., translators, graphic agencies).
Labelling
- Act as Affiliate Labelling Responsible Person (ALRP), ensuring compliant product information.
- Follow global labelling procedures and address local regulatory requirements.
Process Improvement
- Drive internal regulatory initiatives and provide affiliate training.
- Build relationships with key regulatory officials for strategic alignment.
Optional Responsibilities
- Assist in pharmacovigilance reporting and product quality tasks.
- Support local quality standards and product complaint systems.
Qualifications
| Requirement | Details |
|---|---|
| Education | Bachelor’s in a relevant scientific field (e.g., Pharmacy, Life Sciences) |
| Experience | 1+ years in regulatory affairs with external agency interaction |
| Skills | Knowledge of local regulations, ICH GCP, and quality systems |
| Language | Proficient in written and spoken English |
Additional Preferences
- Strong analytical, problem-solving, and negotiation skills.
- Project management and priority-setting capabilities.
- Experience with regulatory IT tools and quality systems.
Why Join Lilly?
Lilly fosters a collaborative environment focused on patient outcomes. With a 3.7/5 rating for work-life balance in Gurgaon, we offer growth and impact in a dynamic industry.
Benefits
- Global Impact: Support groundbreaking treatments for critical diseases.
- Career Growth: Access training in regulatory and compliance strategies.
- Collaborative Culture: Work with cross-functional teams in a ‘One India’ framework.
- Inclusive Workplace: Join a diverse team of over 1,000 in India.
How to Apply
Apply via Lilly Careers (Job ID: R-78426). Submit your resume and cover letter highlighting regulatory experience. For accommodations, complete the Workplace Accommodation Form.
Application Tips
- Emphasize experience with regulatory submissions and agency interactions.
- Highlight familiarity with SUGAM or SAP systems.
- Review trends at PharmaTimes.
Verified by Trusted HRs
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Work Environment
- Location: Gurgaon, Haryana, India (hybrid possible, 30% office-based per reviews).
- Travel: Minimal, primarily for regulatory meetings.
- Setting: Modern office in Gurgaon’s commercial hub.
Equal Opportunity Employer
Lilly is committed to diversity, ensuring equal opportunities regardless of age, race, gender, or disability.
Important Notice
Lilly never requests payment or personal information during hiring. Report suspicious activity to cybercrime.gov.in.
Take the Next Step
Join Lilly as a Manager / Senior Manager – Regulatory Affairs in Gurgaon. Apply by June 30, 2025, to shape the future of healthcare
