GlaxoSmithKline (GSK), a global biopharmaceutical leader, is hiring a Regulatory Specialist – Submission Delivery Excellence for its global regulatory operations team. This is a full-time opportunity offering hands-on exposure to end-to-end regulatory submissions, lifecycle management, and collaboration with cross-functional global teams.
This role is ideal for professionals seeking to build or advance a career in Regulatory Affairs, global submissions, and regulatory compliance within a world-class biopharma organization.
🏢 Company Overview – GSK
GSK is a global biopharma company committed to uniting science, technology, and talent to get ahead of disease. With a strong focus on vaccines and specialty medicines, GSK impacts billions of lives worldwide across therapeutic areas including respiratory, oncology, HIV, immunology, and infectious diseases.
📍 Job Location
- Bengaluru – Luxor North Tower, India
- Poznań, Poland (Hybrid work model)
📅 Job Details
- Position: Regulatory Specialist – Submission Delivery Excellence
- Job ID: 434141
- Employment Type: Full-Time
- Posted On: Today
- Application Deadline: 31 January 2026
🔑 Key Responsibilities (Regulatory Specialist Jobs)
As a Regulatory Specialist at GSK, you will:
- Deliver marketing authorization applications and lifecycle maintenance submissions
- Manage product renewals, site registrations, and variation submissions
- Coordinate Module Submission Readiness (MSR) and execute dossier strategies
- Handle end-to-end regulatory submission delivery in compliance with global regulations
- Coordinate regulatory samples with manufacturing sites and third-party vendors
- Identify, assess, and escalate regulatory risks impacting submission timelines
- Support PBRER and post-approval submissions
- Participate in process improvement initiatives
- Mentor and train junior regulatory team members
🎓 Qualifications & Skills Required
✅ Educational Background
- Degree in Pharmacy, Life Sciences, Biotechnology, or Healthcare
- Or extensive hands-on experience in Regulatory Affairs
✅ Key Skills
- Strong understanding of pharmaceutical regulations and global submission processes
- Ability to interpret regulatory guidelines and SOPs
- Experience working in matrix and cross-functional teams
- Excellent written and verbal communication
- Strong organizational, planning, and risk-management skills
- Ability to lead regulatory discussions and submission meetings
💼 Salary & Benefits
💰 Estimated Salary (India – Bengaluru)
- ₹12,00,000 – ₹22,00,000 per annum (based on experience & role level)
🎁 Benefits
- Performance-based bonuses
- Private healthcare coverage
- Paid parental & family care leave
- Career development and global exposure
- Inclusive and supportive work culture
📝 How to Apply
