Global Regulatory Strategy Director

GlaxoSmithKline; Philadelphia (Philadelphia County); Hybride; USD 172 000 - 286 000; Plein temps

Résumé du poste

GSK is seeking an experienced regulatory leader to join our Global Regulatory Strategy organisation, supporting the Respiratory, Immunology and Inflammation portfolio. This role is based in the United States, United Kingdom or Belgium and offers a hybrid working model, with balance of office and remote work.

You will develop and lead global/regional regulatory strategies, guide cross-functional teams, manage health-authority interactions and regulatory submissions, and shape evidence-based

Qualifications

• Bachelor's degree or equivalent in biological/health sciences.
• Significant regulatory-affairs experience across pharmaceutical development and lifecycle.
• Experience leading regulatory submissions and health-authority interactions.
• Knowledge of clinical-trial and marketing-authorisation requirements in major markets.

Responsabilités

• Develop and execute global and regional regulatory strategies for Respiratory, Immunology and Inflammation assets.
• Ensure regulatory strategy aligns with development plans and market requirements.
• Provide strategic regulatory leadership to cross-functional development teams.
• Lead health-authority interactions and regulatory submissions.
• Identify opportunities using regulatory intelligence to inform development decisions.
• Collaborate with clinical, safety, medical and commercial teams.

Connaissances

Regulatory leadership

Cross-functional teamwork

Regulatory strategy

Health authorities

Regulatory submissions

Global regulatory knowledge

Formation

Bachelor's in biological/health sciences

Master's/PhD in regulatory science

Description du poste

GSK is seeking an experienced regulatory leader to join our Global Regulatory Strategy organisation, supporting the Respiratory, Immunology and Inflammation portfolio. This role is based in the United States, United Kingdom or Belgium and offers a hybrid working model, with balance of office and remote work.

You will develop and lead global/regional regulatory strategies, guide cross-functional teams, manage health-authority interactions and regulatory submissions, and shape evidence-based