GSK Career Opportunity: Regulatory Project Manager (CMC Mature Vx Delivery Lead)
Pharm'Up 
GSK, a global biopharma leader, is seeking a high-caliber Regulatory Project Manager to join their team in Bengaluru. This role focuses on the CMC (Chemistry, Manufacturing, and Controls) lifecycle management of registered vaccine products, ensuring that life-saving medicines remain available and compliant across global markets.
Role Overview
As the CMC Mature Vx Delivery Lead, you will be responsible for the end-to-end management of complex regulatory submissions. This includes post-approval variations and responding to Health Authority Questions (HAQs) for Active Pharmaceutical Ingredients (APIs) and Finished Products.
- Location: Bengaluru, India
- Req ID: 433514
- Application Deadline: 10th February 2026
Key Responsibilities
- Submission Leadership: Plan and execute complex CMC regulatory submissions (specifically CTD Module 3) for the global Vaccines portfolio.
- Risk Management: Identify data risks in submission packages and develop robust mitigation strategies.
- Stakeholder Collaboration: Partner with Global Supply Chain (GSC), Quality Assurance (QA), and Local Operating Companies (LOCs) to ensure dossier accuracy.
- Process Innovation: Identify and implement simplified working practices to improve CMC regulatory efficiency.
- Mentorship: Act as a Subject Matter Expert (SME), guiding junior team members and building organizational capability.
Candidate Profile
Educational Background
- Advanced Degree (Master’s or Ph.D.) in Pharmacy, Biotechnology, Biology, Chemistry, Biochemistry, or a related Life Science field.
Professional Experience
- CMC Expertise: Strong experience in CMC Regulatory Affairs within the pharmaceutical industry.
- Technical Proficiency: Extensive expertise in CTD Module 1-3 preparation and technical dossier review.
- Regulatory Knowledge: Deep understanding of ICH guidelines and the EU regulatory framework.
Core Competencies
- Analytical Thinking: Ability to handle multiple tasks and prioritize high-quality output under tight deadlines.
- Communication: Exceptional English writing skills and the ability to build relationships across a large, diverse organization.
- Growth Mindset: Flexibility and a proactive approach to continuous improvement.
How to Apply
Interested candidates should apply through the GSK Careers portal using the Req ID 433514. Ensure your CV highlights your specific experience with Post-approval variations and Module 3 Quality sections.
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