Looking to start your career in Regulatory Affairs with one of the world’s leading pharmaceutical companies? Novartis has announced openings for RA GRSSC Interns in Hyderabad. This internship offers an excellent opportunity for students and fresh graduates interested in regulatory submissions, clinical documentation, FDA compliance, electronic publishing, and regulatory operations.

If you’re passionate about the pharmaceutical industry, clinical research, and global regulatory processes, this Novartis Regulatory Affairs Internship 2026 could be your gateway into the life sciences industry.

About Novartis

Novartis is a global healthcare company dedicated to reimagining medicine to improve and extend people’s lives. Operating in more than 140 countries, Novartis develops innovative medicines across multiple therapeutic areas while maintaining world-class regulatory and quality standards.

The company’s Hyderabad Global Service Center supports worldwide regulatory operations, clinical development, and digital transformation initiatives.

Job Details

Key Responsibilities

Selected interns will gain practical exposure to global regulatory operations and will be responsible for:

• Support Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions and Protocol Amendments.
• Assist with New Investigator submissions according to FDA regulations.
• Perform monthly reconciliation of regulatory submissions.
• Support regulatory compliance activities using DRAGON Regulatory Information Management System.
• Assist Regulatory Managers in preparing and releasing submissions to health authorities.
• Compile, integrate, publish and archive regulatory and clinical documents.
• Work with electronic publishing software and document management systems.
• Maintain knowledge of electronic publishing standards and regulatory guidelines.
• Update Regulatory Information Management Systems with product information.
• Support Periodic Reports, Renewal submissions and Portfolio Transformation submissions.
• Assist in registration sample procurement and certificate management.
• Participate in document quality review and submission tracking.
• Complete all mandatory compliance and training activities.

Required Qualifications

Candidates with the following educational backgrounds are encouraged to apply:

• B.Pharm
• M.Pharm
• Pharm.D
• M.Sc Life Sciences
• Biotechnology
• Clinical Research
• Biomedical Sciences
• Other relevant Life Science disciplines

Freshers and students interested in Regulatory Affairs are encouraged to apply.

Desired Skills

Applicants should possess:

• Basic understanding of Regulatory Affairs
• Knowledge of FDA regulations (preferred)
• Understanding of clinical documentation
• Good documentation skills
• Strong MS Office knowledge
• Excellent communication skills
• Attention to detail
• Ability to work in cross-functional teams
• Willingness to learn electronic publishing
• Time management skills

What You Will Learn

This internship provides hands-on exposure to:

• Regulatory Affairs Operations
• FDA Submission Process
• Clinical Trial Documentation
• DSUR Preparation
• Annual Report Submissions
• Regulatory Compliance
• Electronic Publishing
• Document Management Systems
• Regulatory Information Management (RIM)
• Global Regulatory Processes

Benefits

• Internship with a globally recognized pharmaceutical company
• Industry-leading Regulatory Affairs exposure
• Hands-on experience with FDA submission processes
• Opportunity to work alongside experienced regulatory professionals
• Learning global regulatory compliance practices
• Professional development and training
• Strong career foundation in Regulatory Affairs

Why Join Novartis?

Working at Novartis allows interns to:

• Build expertise in global pharmaceutical regulations.
• Learn industry-standard regulatory submission processes.
• Gain experience with international health authority requirements.
• Work in a collaborative and innovation-driven environment.
• Develop skills that are highly valued across pharmaceutical companies and CROs.

How to Apply

Application Link