Novartis is hiring a Regulatory Affairs Associate for its Hyderabad office. This opportunity is ideal for life sciences professionals interested in regulatory affairs, clinical trials, regulatory submissions, dossier preparation, regulatory compliance, and project management. Candidates with strong documentation skills, attention to detail, and experience supporting regulatory activities are encouraged to apply.
If you’re looking for Regulatory Affairs Associate jobs in Hyderabad, Novartis careers for life sciences graduates, or pharma regulatory affairs jobs in India, this role offers an excellent opportunity to work with one of the world’s leading pharmaceutical companies.
Job Details
| Particular | Details |
|---|---|
| Company | Novartis |
| Position | Regulatory Affairs Associate |
| Job Type | Full-Time |
| Location | Hyderabad, Telangana (Office) |
| Department | Regulatory Affairs |
| Experience | Relevant experience preferred |
| Application Deadline | June 26, 2026 |
| Job ID | REQ-10078046 |
Key Responsibilities
The selected candidate will be responsible for:
- Preparing and coordinating high-quality regulatory submissions.
- Supporting CTA, NDA, and supplemental regulatory applications.
- Maintaining regulatory dossiers, databases, and documentation.
- Ensuring timely submission of license renewals.
- Supporting CMC, BPI, PSUR, and RMP documentation.
- Updating regulatory master files.
- Coordinating meetings with health authorities when required.
- Responding promptly to regulatory authority queries.
- Tracking registration samples, certificates, and dossiers.
- Maintaining compliance with company SOPs and regulatory guidelines.
- Reporting technical complaints, adverse events, and special cases within required timelines.
- Collaborating with global and regional regulatory teams.
Required Qualifications
Candidates should possess:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related disciplines.
- Understanding of Regulatory Affairs processes.
- Knowledge of Clinical Trials and Regulatory Compliance.
- Excellent documentation and database management skills.
- Strong attention to detail.
- Good communication skills in English.
- Project planning and collaboration abilities.
Desired Skills
- Regulatory Affairs
- Regulatory Compliance
- Clinical Trials
- Regulatory Submissions
- Dossier Preparation
- Databases Management
- Documentation
- Project Management
- Cross-functional Collaboration
- Operations Management
- Attention to Detail
- Life Sciences
Why Join Novartis?
Working at Novartis offers:
- Opportunity to work with a globally recognized pharmaceutical leader.
- Exposure to international regulatory submission processes.
- Collaborative and inclusive work culture.
- Career development and continuous learning opportunities.
- Global regulatory affairs experience.
- Stable long-term career growth.
How to Apply
