Are you an experienced regulatory professional looking to make an impact in the global pharmaceutical industry? GSK (GlaxoSmithKline) is hiring a Senior Regulatory Specialist to join its SMMP Delivery Team. This pivotal role offers the chance to lead global Chemistry, Manufacturing, and Control (CMC) variation projects and contribute to regulatory excellence in drug development and global supply chain management.
This is your opportunity to work with a leading global biopharma company and ensure timely, compliant delivery of high-quality regulatory dossiers across markets worldwide.
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Key Responsibilities
As a Senior Regulatory Specialist at GSK, you will:
- Manage multiple CMC variation projects, source transfers, and respond to Health Authority Questions (HAQs).
- Work with CTD Module 3 (Quality section) for APIs, intermediates, and drug products.
- Execute dossier strategies and perform data assessments to ensure compliance with GSK processes and international regulatory requirements (US, EU, and global).
- Prepare and coordinate submission-ready regulatory documents.
- Collaborate with Global Supply Chain, Regulatory Affairs teams, and Local Operating Companies.
- Provide guidance on CMC regulatory procedures and mentor new team members.
- Monitor regulatory intelligence and act proactively on global regulatory changes.
- Drive improvements in CMC regulatory processes, policies, and systems.
Qualifications & Skills
- Education: Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, Chemical Technology, or related field.
- Experience: Proven regulatory affairs expertise in the pharmaceutical industry, with strong knowledge of post-approval CMC regulatory procedures.
- Familiarity with ICH CTD documentation (Modules 2 & 3).
- Strong understanding of pharmaceutical development and regulatory processes.
- Excellent communication skills in English, with attention to detail and accuracy.
- Ability to manage multiple projects, deadlines, and priorities effectively.
What GSK Offers
- Career with purpose – Be part of a mission-driven company improving global health.
- Non-wage benefits: Medical care, life insurance, pension scheme, sports card, recreation allowance, preventive healthcare.
- Hybrid work model – 2-3 days office presence per week.
- Growth opportunities at a leading global healthcare company.
- Supportive and diverse workplace culture.
Job Details
- Position: Senior Regulatory Specialist
- Company: GSK (GlaxoSmithKline)
- Location: Bengaluru, India (Luxor North Tower)
- Job Type: Full-time, Hybrid
- Posted on: October 3, 2025
- Application Deadline: November 4, 2025
💡 Salary Range (Estimated): ₹12,00,000 – ₹18,00,000 per annum (based on industry standards).
How to Apply
