Director, Global Regulatory Strategy – Oncology

GlaxoSmithKline plc; Rockville (MD); Hybrid; USD 172,000 - 286,000; Full time

Job summary

GSK, a global biopharma company, seeks a Director, Global Regulatory Strategy to provide strategic regulatory leadership for oncology assets. You will guide development programs across global and regional teams, shaping innovative regulatory strategies and ensuring alignment with priority markets throughout development, registration and lifecycle management.

You will lead cross-functional oncology development teams, translate complex data into clear regulatory recommendations, and manage

Qualifications

• Bachelor’s degree or equivalent in a relevant field.
• 5+ years in regulatory affairs across pharmaceutical development and lifecycle.
• Experience delivering regulatory strategies for oncology programs.
• Experience leading regulatory submissions and approvals.
• Experience coordinating interactions with health authorities.

Responsibilities

• Develop and execute global and regional regulatory strategies for oncology assets and development programs.
• Ensure regulatory strategy aligns with development plans and priority markets.
• Provide leadership to cross-functional oncology development teams.
• Identify opportunities and risks from regulatory intelligence and landscape.
• Translate complex data into clear regulatory recommendations for decisions.
• Lead regulatory pathway design, including accelerated pathways and biomarkers where applicable.
• Coordinate regulatory activities across functions and geographies.
• Lead health-authority interactions, submissions and milestone meetings.
• Collaborate with clinical, safety, medical, commercial, and local regulatory colleagues.
• Shape labeling approaches based on evidence and regulations; manage emerging issues.
• Ensure compliance with regulatory requirements throughout lifecycle.
• Present regulatory perspectives to senior leaders and authorities.
• Contribute regulatory insights to due diligence and business development.
• Leverage digital capabilities and regulatory intelligence to improve decision-making.

Skills

Regulatory Strategy

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Regulatory Compliance

Resource Management

Stakeholder Management

Education

Bachelor’s degree in biological science or healthcare science

Master’s degree or PhD (preferred)

Job description

GSK, a global biopharma company, seeks a Director, Global Regulatory Strategy to provide strategic regulatory leadership for oncology assets. You will guide development programs across global and regional teams, shaping innovative regulatory strategies and ensuring alignment with priority markets throughout development, registration and lifecycle management.

You will lead cross-functional oncology development teams, translate complex data into clear regulatory recommendations, and manage