Global Regulatory Strategy Lead - Oncology

GSK; Waver; Hybride; EUR 98 000 - 164 000; Plein temps

Résumé du poste

GSK is seeking an Associate Director of Global Regulatory Affairs. This role develops and executes global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance.

You will report to the Global Regulatory Lead and collaborate with cross-functional teams to shape development plans and regulatory interactions across regions. You will lead with a patient-first mindset, driving strategic changes, stakeholder engagement, and

Qualifications

• Bachelor’s degree in biological, pharmaceutical or healthcare science.
• Experience in all phases of drug development in regulatory affairs, preferably oncology.
• Experience with clinical trial and licensing requirements in major regions.
• Experience leading regional development, submission and approval activities.
• Strong written and verbal communication; senior stakeholder management.
• Experience working in matrix teams.

Responsabilités

• Develop and deliver robust regulatory strategies with GRL and regional teams.
• Collaborate with cross-functional teams to align regulatory plans with asset strategy.
• Support interactions, reviews and submissions with regional authorities.
• Assess regulatory intelligence to inform strategy and decision-making.
• Ensure compliance across product lifecycle and drive process improvements.

Connaissances

Regulatory strategies

Stakeholder management

Regulatory compliance

Matrix leadership

Digital fluency

Communication

Business resilience

Resource management

Formation

Bachelor’s degree in biological, pharmaceutical or healthcare science

Description du poste

GSK is seeking an Associate Director of Global Regulatory Affairs. This role develops and executes global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance.

You will report to the Global Regulatory Lead and collaborate with cross-functional teams to shape development plans and regulatory interactions across regions. You will lead with a patient-first mindset, driving strategic changes, stakeholder engagement, and