Regulatory Project Manager Job At GSK
GSK is hiring a Regulatory Project Manager (Delivery Lead) to support global vaccine products through complex CMC regulatory submissions. This Manager Job role plays a critical part in ensuring regulatory compliance, continuity of supply, and timely delivery of life-saving vaccines across multiple international markets. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
Job Details
- Job Title: Regulatory Project Manager (Delivery Lead)
- Location: Bengaluru, India | Worli, Mumbai, India | Cairo, Egypt | Poznan, Poland | Warsaw, Poland
About the Company
GSK (GlaxoSmithKline) is a global biopharma company with a mission to unite science, technology, and talent to get ahead of disease together. GSK focuses on vaccines and specialty medicines across therapeutic areas, including respiratory, immunology, oncology, HIV, and infectious diseases, aiming to positively impact billions of lives worldwide. This Manager Job role plays a significant role in the company.
Educational Requirements
- Master’s degree or higher in Pharmacy
- Strong experience in CMC Regulatory Affairs within the pharmaceutical or research industry
Key Responsibilities
- Lead and manage complex CMC regulatory submissions, including post-approval variations and Health Authority interactions
- Coordinate planning, execution, and delivery of CMC regulatory activities across multiple vaccine projects
- Handle Health Authority Questions (HAQs) for Finished Products, Intermediates, and APIs
- Identify regulatory risks and support mitigation strategies
- Collaborate with Global Regulatory teams, Supply Chain, QA, Local Operating Companies, and third-party manufacturers
- Contribute to CMC dossier preparation, review, and lifecycle maintenance (CTD Module 3)
- Drive continuous improvement of CMC regulatory processes and systems
- Act as Subject Matter Expert (SME) and mentor team members within CMC Regulatory Affairs
Skills Required
- Strong expertise in CMC Regulatory Affairs and dossier preparation (CTD Modules 1–3)
- Sound understanding of ICH guidelines, EU regulatory framework, and global regulatory processes
- Excellent analytical thinking, flexibility, and growth mindset
- Strong written and verbal communication skills in English
- High attention to detail with the ability to manage multiple priorities and deadlines
- Proven stakeholder management and cross-functional collaboration skills
Why This Job Role?
The Manager Job role at GSK offers a unique opportunity to work on global vaccine programs, lead high-impact regulatory initiatives, drive innovation in CMC delivery, and contribute directly to improving patient lives worldwide—all within a purpose-driven, inclusive organization. Graduates seeking M Pharma jobs or Pharmacy jobs can apply now.
