Regulatory Project Manager Jobs at GSK | Global Life Science Jobs | Apply Now
Looking for a high-impact Regulatory Project Manager role in global vaccines? GSK Careers presents an exceptional opportunity for professionals seeking advanced Life Science Jobs in CMC Regulatory Affairs, where innovation, compliance, and patient impact come together in a globally recognized biopharma organization.
- Job Title: Regulatory Project Manager
- Locations: Bengaluru, Mumbai
- Site Name: Bengaluru Luxor North Tower, Maharashtra – Worli Mumbai
- Department: Regulatory
- Job ID: 433514
About the Company:
GSK is a leading global biopharmaceutical company focused on preventing and treating disease through innovation in vaccines and specialty medicines. With a strong commitment to science, technology, and talent, GSK aims to positively impact the health of billions worldwide.
Job Overview:
The Regulatory Project Manager (CMC Delivery Lead) supports registered vaccine products by managing complex CMC submissions, post-approval variations, and Health Authority interactions. The role ensures accuracy, quality, and regulatory compliance across global markets while contributing to operational efficiency and innovation within GSK’s vaccine business.
Key Responsibilities:
- Manage complex CMC regulatory submissions across vaccine portfolios
- Coordinate CMC variations and Health Authority Questions (HAQs)
- Support lifecycle management of registered vaccine products
- Collaborate with Global Regulatory, Supply Chain, QA, and third parties
- Identify regulatory risks and implement mitigation strategies
- Act as SME in CMC Regulatory Affairs and mentor team members
- Improve regulatory processes to enhance efficiency and quality
Educational Requirements:
- Master’s degree or higher in Biotechnology, Biology, Biochemistry, or related life science discipline
Skills Required:
- Strong experience in CMC Regulatory Affairs
- Expertise in CTD Modules 1–3 and regulatory dossier preparation
- Knowledge of ICH guidelines and EU regulatory frameworks
- Excellent communication and stakeholder management skills
- Strong organizational, analytical, and multitasking abilities
- High attention to detail and regulatory compliance accuracy
This Regulatory Project Manager role at GSK offers a unique opportunity to contribute to global vaccine delivery while advancing your career in Life Science Jobs. Join GSK Careers to make a measurable impact on global health through regulatory excellence.
