Global biopharma leader GSK is hiring a Regulatory Specialist (CMC) for its Bengaluru Luxor North Tower location. This full-time, hybrid opportunity is ideal for professionals with experience in CMC regulatory affairs, NDA/BLA annual reports, and global post-approval submissions.
If you have at least 2 years of experience in CMC regulatory activities and want to work on NDAs, BLAs, DMFs, Canadian Annual Notifications, and Brazil/China CMC Annual Reports, this role offers strong career growth in global regulatory operations.
Application Deadline: 23 February 2026
Location: Bengaluru (Hybrid Model)
Job Requisition ID: 435916
🔬 About the Role – Regulatory Specialist (CMC)
As a Regulatory Specialist at GSK, you will be responsible for planning, preparing, reviewing, and delivering CMC Annual Reports across GSK’s global Pharma (Rx) and Vaccine (Vx) portfolio.
This role directly supports regulatory compliance for established products while ensuring alignment with worldwide post-approval requirements.
Primary keywords targeted:
- Regulatory Specialist Bengaluru
- CMC Regulatory Affairs jobs
- NDA BLA Annual Reports
- Pharmaceutical Regulatory Jobs India
- GSK Regulatory Specialist vacancy
📌 Key Responsibilities
- Prepare and technically review CMC Annual Reports for:
- NDAs (New Drug Applications)
- BLAs (Biologics License Applications)
- DMFs (Drug Master Files)
- Canadian Annual Notifications
- Brazil & China CMC Annual Reports
- Collaborate with:
- Local Operating Companies (LOCs)
- Manufacturing sites
- Product Owners
- Global Submission Leads
- Ensure compliance with worldwide post-approval CMC regulatory requirements
- Monitor regulatory intelligence updates and implement changes
- Manage multiple global submissions with high accuracy
- Contribute to digital capability enhancement within regulatory operations
- Provide training and mentoring when required
🎓 Qualifications Required
Basic Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field
- Minimum 2 years’ experience in CMC regulatory affairs
- Knowledge of global post-approval CMC requirements
- Fluent English (written and spoken)
Preferred Qualifications:
- Experience with CTD/eCTD documentation
- Knowledge of global regulatory submissions
- Understanding of drug development and manufacturing processes
💼 Why Join GSK?
GSK is a global biopharma company focused on preventing and treating disease through innovation in vaccines and specialty medicines.
Key therapeutic areas:
- Respiratory
- Immunology & Inflammation
- Oncology
- HIV
- Infectious Diseases
Benefits & Career Growth:
- Exposure to global regulatory frameworks
- Hybrid working model in Bengaluru
- Strong learning curve in CMC post-approval lifecycle management
- Inclusive and collaborative global work culture
- Opportunity to enhance digital regulatory capability
💰 Salary Estimate (India – Regulatory Specialist CMC)
Based on current pharmaceutical regulatory affairs market data in Bengaluru:
Estimated Salary Range: ₹9,00,000 – ₹14,00,000 per annum (CTC)**
(Actual compensation may vary based on experience and internal parity.)
📍 Job Location
Bengaluru Luxor North Tower
Karnataka, India (Hybrid Working Model)
📝 How to Apply
