Regulatory Affairs Manager Job at Eli Lilly, Apply Now!
Join Lilly, a global leader in healthcare and pharmaceuticals, as a Manager/Sr. Manager – Regulatory Affairs in Gurgaon, India. This role focuses on regulatory planning, compliance, dossier preparation, and approvals for new and existing products. If you have a B.Pharm, M.Pharm, or a degree in Chemistry/Biotechnology with 3+ years of experience in regulatory affairs, apply today to be part of a company that prioritizes innovation, compliance, and making life better for people worldwide.
About The Company
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and strive to make life better for individuals globally.
- Job Title: Manager/Sr. Manager-Regulatory Affairs
- Location: Gurgaon, Haryana, India
- Category: Research & Development
- Job Id: R-72432
Purpose
The Manager/Sr. Manager of Regulatory Affairs is responsible for regulatory planning to meet business needs, compliance of regulatory tools, and ensuring regulatory activities are performed
effectively. This role involves preparing submissions, gaining approvals for new products, maintaining compliance for marketed products, and staying updated on changes in the regulatory environment.Primary Responsibilities
- Regulatory Planning
- Regulatory Plan Development
- Process Management
- Regulatory Tools
- Submissions and Approvals
- Dossier Preparation
- Gain Regulatory Approval
- Metrics Review
- Regulatory Compliance
- Regulatory Influence
- External
- Internal
- Additional Responsibilities
Minimum Qualification Requirements
B.Pharm, M. Pharm, BSc or Master’s Degree in Chemistry or Biotechnology or related areas, or MD with a minimum of 3 years of regulatory affairs or related experience. In-depth knowledge of local regulations and corporate policies is essential.
Other Information/Additional Preferences
Good knowledge of English, competent project management skills, analytical skills, customer focus, and creative thinking are desired qualities.
Keywords: Regulatory Affairs, Manager, Sr. Manager, Pharmaceutical, Healthcare, Gurgaon, Haryana, India
