Regional Regulatory Affairs Director (International)

Experteer Overview

In this role you lead regional regulatory strategy development and execution for assigned assets, aligning with global plans and local requirements. You will collaborate with GRLs, LOC RA, and regional leads to optimize timing and labeling for multiple markets. You’ll navigate a complex stakeholder network to secure early approvals and ensure regulatory readiness across regions. This position offers an opportunity to shape regional strategy within a global regulatory framework and drive impact for patients.Retribuzione / Benefits

• Develop and deliver optimal regional regulatory strategy according to plan
• Serve as regional single point of contact for asset regulatory activities and cross-functional liaison
• Provide deep regulatory knowledge and market‑specific expertise to anticipate opportunities/risks
• Assess regulatory intelligence and translate updates into actionable insights
• Implement regionally aligned regulatory strategy in compliance with local requirements and GSK policiesRepresent regulatory in regional governance and cross-functional forums
• Coordinate with GRL and LOC RA on early development and submission planning
• Drive early engagement with LOC RAs for launch readiness and regional input into global strategy
• Lead regional innovation initiatives aligned to GRA objectives
• Mentor team members and drive continuous improvement in regulatory plans

Responsabilità

• Bachelor Degree in a scientific discipline; extensive experience in regional development, submissions and approvals
• Proven experience across drug development regulatory affairs in multiple regions
• Strong knowledge of clinical trials and licensing requirements in major regional markets
• Ability to manage multi-year planning with matrix leadership up to VP level
• Experience collaborating with Health Authorities and cross-functional teams

Requisiti fondamentali

• private healthcare
• paid time off
• life insurance
• private pension plan
• fully paid parental leave
• bonus potential and/or long-term incentive program

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