Global Regulatory Strategy Director — Lead Global Approvals

GSK; Waver; Hybrid; EUR 112,000 - 186,000; Full time

Job summary

GSK in Belgium is seeking an experienced Director, Global Regulatory Strategy to lead regulatory planning for Respiratory, Immunology and Inflammation assets. You will shape development programmes, interact with health authorities and steer cross‑functional teams across regions.

The role requires strategic insight, strong communication, and a track record of guiding submissions and milestone meetings to deliver timely, evidence‑based regulatory decisions across the product lifecycle.

Qualifications

• Bachelor's degree or equivalent in biological/health science.
• Significant regulatory-affairs experience across drug development and lifecycle.
• Experience developing regulatory strategies for development programmes.
• Experience leading regulatory submission and approval activities.
• Track record of leading health-authority interactions.
• Experience guiding global, cross-functional matrix teams.
• Strong knowledge of clinical-trial and marketing-authorisation requirements.

Responsibilities

• Develop and execute regulatory strategies for assigned assets across global/regional scopes.
• Ensure strategy aligns with development plans and priority markets.
• Lead cross-functional teams and regulatory matrix coordination.
• Lead health-authority interactions and regulatory submissions.
• Provide regulatory leadership within global teams and at milestone meetings.
• Develop labeling approaches based on evidence and regulatory requirements.
• Identify regulatory risks and develop mitigation strategies.
• Represent regulatory perspectives to senior leaders and authorities.

Skills

Regulatory leadership

Strategic thinking

Cross-functional leadership

Influencing

Communication

Education

Bachelor's degree in biological science

Master's degree or PhD (preferred)

Tools

Regulatory submissions

Job description

GSK in Belgium is seeking an experienced Director, Global Regulatory Strategy to lead regulatory planning for Respiratory, Immunology and Inflammation assets. You will shape development programmes, interact with health authorities and steer cross‑functional teams across regions.

The role requires strategic insight, strong communication, and a track record of guiding submissions and milestone meetings to deliver timely, evidence‑based regulatory decisions across the product lifecycle.