Regulatory Affairs Director – Colombia

About the role

GSK is seeking a senior leader to direct regulatory affairs for its pharmaceutical and vaccine portfolio in Colombia. Reporting to the VP of Regulatory Affairs for Latin America & International, the Director will shape strategy, ensure compliance, and accelerate patient access across the product lifecycle.

Key responsibilities

• Lead the regulatory strategy for Colombia, overseeing product registrations, lifecycle management and alignment with local, regional and global business priorities.
• Represent GSK with health authorities, industry associations and external stakeholders, building trusted relationships and influencing the regulatory environment.
• Provide strategic regulatory leadership while actively managing critical submissions, complex negotiations and risk assessments.
• Partner with cross‑functional teams to enable product launches, portfolio optimization and business continuity, ensuring regulatory approaches support business goals.
• Monitor regulatory landscape changes, assess business impact, identify risks and opportunities, and develop proactive strategies for sustainable growth.
• Drive operational excellence by optimizing processes, strengthening governance, ensuring inspection readiness and implementing digital solutions and global best practices.
• Build, coach and develop a high‑performing regulatory team.

Required profile

• Strategic, business‑facing leader with deep regulatory expertise in pharmaceuticals or vaccines.
• Hands‑on experience in product registration and lifecycle management within Colombia.
• Proven ability to engage with health authorities and industry bodies.
• Strong collaborative skills to work across functions and regions.
• Track record of anticipating regulatory changes and translating them into actionable business strategies.

Required skills