Looking for the latest Regulatory Affairs jobs in Hyderabad? Here’s an excellent opportunity to join Novartis, one of the world’s leading pharmaceutical companies. Novartis is hiring a Regulatory Affairs Associate for its Hyderabad office. This role is ideal for candidates interested in regulatory submissions, dossier preparation, regulatory compliance, clinical trial documentation, and pharmaceutical regulatory affairs.
If you’re looking to build a long-term career in Regulatory Affairs (RA) with a global pharmaceutical company, this opportunity offers exposure to international regulatory processes, cross-functional collaboration, and global product registrations.
Job Overview
| Details | Information |
|---|---|
| Company | Novartis |
| Job Role | Regulatory Affairs Associate |
| Job Location | Hyderabad, Telangana |
| Job Type | Full-Time |
| Department | Regulatory Affairs |
| Experience | Relevant Regulatory Affairs/Pharma experience preferred |
| Last Date to Apply | 24 July 2026 |
About Novartis
Novartis is a global healthcare company committed to reimagining medicine to improve and extend people’s lives. With operations across more than 100 countries, Novartis develops innovative medicines while maintaining the highest standards of quality, patient safety, and regulatory compliance.
Working at Novartis provides professionals with international exposure, structured career growth, and opportunities to contribute to global healthcare innovation.
As a Regulatory Affairs Associate, you will support regulatory operations and ensure timely submissions to health authorities.
Major responsibilities include:
- Prepare and coordinate high-quality regulatory submissions.
- Support CTA, NDA, and supplementary application submissions.
- Maintain regulatory dossiers and submission documentation.
- Ensure timely license renewal submissions.
- Support CMC documentation and regulatory maintenance.
- Manage PSUR and RMP submission activities.
- Maintain regulatory databases and archives.
- Track regulatory certificates, dossiers, and registration samples.
- Communicate with Health Authorities regarding regulatory queries.
- Coordinate regulatory documentation across global teams.
- Maintain registration master files.
- Follow Novartis SOPs and regulatory procedures.
- Report product complaints, adverse events, and special case scenarios within required timelines.
- Support artwork-related regulatory activities where applicable.
Candidates with the following educational qualifications are encouraged to apply:
- B.Pharm
- M.Pharm
- Pharm.D
- MSc (Life Sciences)
- Biotechnology
- Biochemistry
- Microbiology
- Biomedical Sciences
- Other relevant Life Sciences degrees
Successful candidates should possess:
- Regulatory Affairs knowledge
- Regulatory Compliance
- Clinical Trial understanding
- Regulatory dossier preparation
- Documentation management
- Database management
- Project planning
- Cross-functional collaboration
- Attention to detail
- Excellent communication skills
- English proficiency
Joining Novartis offers several career advantages:
- Global pharmaceutical organization
- International regulatory exposure
- Opportunity to work on innovative medicines
- Excellent career progression
- Learning-focused work culture
- Cross-functional collaboration
- Exposure to global regulatory submissions
- Strong employee development programs
- Competitive compensation and benefits
This opportunity is suitable for professionals interested in:
- Regulatory Affairs
- Pharmaceutical Regulatory Affairs
- Clinical Regulatory Operations
- Regulatory Documentation
- Global Regulatory Submission
- Drug Registration
- Regulatory Compliance
- CMC Documentation
- Pharma Operations
Join our Official WhatsApp Channel Click Here