Biotech Jobs | GSK is Hiring Senior Regulatory Specialist | Apply Now
Looking for high-impact Biotech Jobs, Regulatory Affairs Jobs, or aiming to build a strong GSK Career? GSK is offering an exciting opportunity for experienced regulatory professionals to join their Regional Projects Team under CMC Excellence. This role is perfect for candidates who want to accelerate their global regulatory expertise while contributing to meaningful healthcare solutions.
Job Details
- Job Title: Senior Regulatory Specialist, Regional Projects Team, CMC Excellence
- Location: Bengaluru, India
- Category: Regulatory
- Job ID: 431909
About the Company
GSK (GlaxoSmithKline) is a global biopharmaceutical leader committed to improving global health and positively impacting 2.5 billion people by 2030. With a strong focus on vaccines and medicines, GSK blends scientific innovation, emerging technologies, and world-class talent to get ahead of disease together. Their R&D strategy is powered by deep immunology expertise, AI-driven insights, and a pipeline designed to address some of the world’s most pressing health challenges. GSK fosters a culture centered on patient impact, accountability, research excellence, and ethical innovation — making it one of the most aspirational paths for those pursuing a GSK Career in regulatory sciences or biotech.
Basic Qualifications
- Bachelor’s degree in Biotechnology or related scientific field
- Minimum 3 years’ experience in Regulatory Affairs (preferably CMC)
- Strong understanding of CTD (Module 2 & 3) and global regulatory pathways
Preferred Qualifications
- Master’s degree or higher in a scientific discipline
- Knowledge of European regulatory requirements & ICH guidelines
- Experience working with eCTD and digital documentation tools
- Experience mentoring or training others
Key Responsibilities
- Manage multiple CMC regulatory projects across Pharma and Vaccines
- Develop and execute regulatory strategies for assigned submissions
- Perform detailed assessments to ensure compliant dossier creation
- Identify and mitigate regulatory risks
- Escalate critical issues and provide strategic solutions
- Maintain updated knowledge of regional/global regulatory guidelines
- Support digital transformation in regulatory systems
- Act as a Subject Matter Expert (SME) for CMC regional submissions
- Collaborate with internal and global GSK teams for timely dossier delivery
- Mentor junior team members
Skills
- Strong communication skills (written and verbal)
- Proficiency in regulatory documentation and eCTD systems
- Attention to detail and quality-focused mindset
- Ability to manage multiple projects under deadlines
- Strong problem-solving and decision-making abilities
- Collaboration skills across global cross-functional teams
If you’re looking for high-growth Biotech Jobs, challenging Regulatory Affairs Jobs, or a rewarding long-term GSK Career, this position offers the perfect opportunity to advance your expertise. With global exposure, digital transformation initiatives, and meaningful contributions to patient health, this role is an ideal fit for ambitious regulatory professionals.
