GlaxoSmithKline (GSK), a global leader in biopharmaceutical innovation, is hiring a Regulatory Project Manager in Regulatory Affairs Operations. This full-time position, available in Bengaluru (Luxor North Tower) and Poznan (Grunwaldzka), offers an exciting opportunity to lead CMC regulatory strategies, oversee complex submissions, and collaborate globally to support product approvals and lifecycle management.
If you have strong experience in regulatory affairs, CMC documentation, and global submissions, this role allows you to play a pivotal part in getting medicines to patients faster—while developing as a technical and regulatory leader.
Key Responsibilities
As a Regulatory Project Manager, you will:
- Independently manage and author complex CMC regulatory dossiers for biopharmaceutical products.
- Define and execute effective regulatory CMC filing strategies aligned with global requirements.
- Interact with regulatory authorities and author responses to agency queries.
- Guide R&D, QA, QC, GSC, and LOC teams with regulatory insights.
- Identify risks in data packages and propose alternative strategies.
- Lead process improvement initiatives within CMC Regulatory Operations.
- Mentor new team members and develop internal Subject Matter Experts (SMEs).
- Represent GSK externally at audits, conferences, and regulatory forums.
Qualifications and Experience
Essential Requirements:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
- 6–7 years of experience in Regulatory Affairs (CMC).
- Strong understanding of drug development, manufacturing, and supply chain processes.
- Proven expertise in handling global CMC submissions and maintaining regulatory compliance.
- Excellent project management, leadership, and stakeholder communication skills.
- Ability to navigate complex global regulatory environments and influence cross-functional teams.
Why Join GSK?
At GSK, you’ll unite science, technology, and talent to get ahead of disease together. The company aims to positively impact the health of 2.5 billion people by 2030, focusing on therapeutic areas such as respiratory, oncology, HIV, and infectious diseases.
Employee Benefits Include:
- Competitive salary and annual performance bonus
- Global career development opportunities
- Inclusive and collaborative work environment
- Access to GSK’s continuous learning and leadership development programs
Application Process
