GlaxoSmithKline (GSK), a leading global biopharma company, is hiring a Regulatory Specialist III – SDE Investigational in Bengaluru, Karnataka. This full-time regulatory affairs position supports global clinical development by preparing and delivering regulatory submissions such as CTA, IND, DSUR, and amendments while ensuring compliance with Health Authority requirements.
If you are looking for a regulatory affairs job in Bengaluru, particularly in clinical trial submissions and investigational regulatory operations, this opportunity at GSK offers strong career growth and global exposure.
🏢 Company Profile – GSK
GSK is a global biopharmaceutical company uniting science, technology, and talent to get ahead of disease together. The company focuses on vaccines and specialty medicines across therapeutic areas including oncology, immunology, HIV, respiratory, and infectious diseases, with the goal of positively impacting 2.5 billion people by the end of the decade.
🎯 Key Responsibilities
- Prepare Clinical Trial Application (CTA) packages for EU and Non-EU regions
- Compile submission components such as IB, Protocol, IMPD, and application forms
- Support CTA amendments, EU End of Trial Notifications (EOTN), and study summaries
- Assist in planning and compilation of DSURs, new INDs, and IND amendments
- Follow Global Regulatory Affairs SOPs, Work Instructions, and How-to Guides
- Coordinate submission delivery activities within regulatory operations teams
- Advocate use of Regulatory Information Management (RIM) systems
- Identify process improvement and efficiency opportunities
- Communicate risks and issues to senior stakeholders
- regulatory submissions experience (CTA, IND, DSUR) and relevant regulatory systems exposure
✅ Basic Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
- 1–4 years of experience in Regulatory Affairs or clinical trial submissions
- Knowledge of global pharmaceutical regulatory procedures
- Understanding of regulations and standards for regulatory applications
- Ability to work independently and in cross-functional global teams
⭐ Preferred Qualifications
- Experience with CTA/IND preparation and submission
- Familiarity with RIM systems or document repositories
- Knowledge of Asia and rest-of-world regulatory requirements
- Experience with quality systems and regulatory compliance
- Exposure to lifecycle activities (site registrations, renewals, variations)
💼 Benefits at GSK
- Competitive salary and benefits package
- Global regulatory exposure
- Continuous learning and career development
- Inclusive and supportive work culture
- Purpose-driven work improving global health
📍 Job Location
Bengaluru (Luxor North Tower), Karnataka, India
📝 How to Apply
