Position: Regulatory Coordinator
Job ID: REQ-10055992
Location: Hyderabad (Office-Based)
Job Type: Full-Time
Novartis, one of the world’s leading pharmaceutical companies, is inviting applications for the role of Regulatory Coordinator at its Hyderabad office. This is an excellent opportunity for professionals looking to build a career in regulatory affairs within a globally renowned organization.
About the Role
As a Regulatory Coordinator (RC), you will work under close supervision to support development, line extensions, and maintenance projects through various stages — including development, regulatory submission, approval, and post-approval commitments.
You will collaborate with global and local regulatory teams, manufacturing and technical operations (NTO), quality assurance, and cross-regional representatives (EU, China, Japan, MoW, LACan) to ensure regulatory goals are achieved effectively and on time.
Key Responsibilities
- Support product registration with a commercially attractive and compliant label.
- Maintain product licenses by managing Chemistry, Manufacturing, and Controls (CMC), Core Data Sheets (CDS), and safety documentation updates.
- Ensure full compliance with company policies (NP4), KRPIA code of conduct, and relevant local and global regulations.
- Coordinate updates in DRAGON system, Risk Management Plans (RMP), packaging, promotional materials, and drug safety reporting.
- Maintain professional relationships with internal teams and external stakeholders.
- Report adverse events, technical complaints, and other special case scenarios within 24 hours of receipt.
- Distribute marketing samples, where applicable.
Key Performance Indicators
- Timely updates and maintenance of product licenses (especially CMC aspects).
- Positive feedback from project stakeholders and cross-functional teams.
- Full compliance with Novartis guidelines, regulatory standards, and legal requirements.
Minimum Requirements
- Exposure to global regulatory processes and cross-cultural collaboration.
- Strong operational management and project execution capabilities.
- Excellent communication and coordination skills.
- Prior experience in regulatory affairs will be an added advantage.
Why Join Novartis?
Novartis is at the forefront of reimagining medicine to improve and extend people’s lives. As part of the team, you will contribute to meaningful projects that impact global health and gain invaluable experience in regulatory operations.
📍 Location: Hyderabad
🔗 Job ID: REQ-10055992
📅 Apply Today and Make a Difference Tomorrow!
