Regional Regulatory Affairs Director (International)

About the role

Lead the development and execution of a high‑quality regional regulatory strategy for assigned assets, ensuring alignment with global regulatory plans and compliance with both GSK policies and regional requirements. Work closely with Global Regulatory Leads, Local Operating Company Regulatory Affairs, and regional medical and commercial teams to deliver optimal labeling and timely approvals.

Key responsibilities

• Develop and deliver an optimal regional regulatory strategy on a multi‑year horizon, coordinating with senior GSK stakeholders.
• Act as the single regional point of contact for assigned assets, liaising between Global Regulatory Leads, medical, commercial, and local regulatory teams.
• Provide deep regulatory knowledge of international markets and therapeutic areas to anticipate risks and opportunities.
• Assess regulatory intelligence, precedent, and competitive landscape, converting updates into actionable insights.
• Proactively implement regional regulatory plans that align with enterprise goals while meeting local requirements.
• Represent the regulatory function in regional stakeholder meetings to ensure timely alignment on strategy and priorities.

Required profile

• Extensive experience in regulatory affairs across multiple international markets.
• Proven ability to lead regional regulatory strategy for complex pharmaceutical assets.
• Strong understanding of therapeutic area regulations and acceleration opportunities.
• Demonstrated success working within a matrix organization at senior levels.
• Excellent stakeholder management and communication skills.

Required skills

• Regulatory intelligence analysis and strategic planning.
• In‑depth knowledge of regional regulatory requirements.
• Stakeholder management across global, regional, and local teams.
• Ability to translate regulatory updates into actionable plans.
• Strategic alignment of regulatory activities with commercial timelines.