Regulatory Specialist - Submission Delivery Excellence

Roles & Responsibilities
• Deliver global marketing authorization applications and lifecycle maintenance submissions
• Manage product renewals, site registrations, and variation submissions
• Coordinate Module Submission Readiness (MSR) and execute dossier strategies
• Handle end-to-end regulatory submission delivery in line with global regulations
• Coordinate regulatory samples with manufacturing sites and third-party vendors
• Identify, assess, and escalate regulatory risks affecting submission timelines
• Support PBRER and post-approval regulatory submissions
• Drive continuous improvement initiatives in regulatory processes
• Mentor and guide junior regulatory team members

Qualification
• Degree in Pharmacy, Life Sciences, Biotechnology, or Healthcare
• Alternatively, relevant hands-on experience in Regulatory Affairs

Experience
• Experience in regulatory submissions, lifecycle management, or global regulatory operations preferred
• Exposure to end-to-end submission delivery is an advantage

Skills
• Strong knowledge of global pharmaceutical regulatory requirements
• Ability to interpret regulatory guidelines, SOPs, and compliance standards
• Excellent coordination and stakeholder management skills
• Strong written and verbal communication abilities
• Good planning, organizational, and risk-management skills
• Ability to lead regulatory discussions and submission meetings

About the Organisation
GlaxoSmithKline (GSK) is a global biopharmaceutical leader focused on vaccines and specialty medicines, uniting science, technology, and talent to advance healthcare and improve lives worldwide.