Global Regulatory Affairs Manager - Oncology | Hybrid

GSK; Irvine; Híbrido; GBP 82 000 - 137 000; Tempo integral

Resumo da oferta

GSK is seeking a Global Regulatory Affairs Manager in Oncology to develop and execute regulatory strategies across global and regional markets, ensuring optimal labeling and approvals while staying compliant with regulatory standards. You will collaborate with GRL and TA heads and engage cross-functional teams to shape development plans and regulatory interactions.

The role is based at GSK HQ in London or Stevenage, with options in Switzerland or Belgium, and offers a hybrid work pattern.

Qualificações

• Bachelor’s degree in biological, pharmaceutical or healthcare science.
• Experience in drug development process and regulatory affairs, oncology preferred.
• Knowledge of clinical trial and licensing requirements in major markets.
• Strong written and verbal communication and experience working in matrix teams.

Responsabilidades

• Develop and execute global/regional regulatory strategies for oncology assets.
• Collaborate with cross-functional teams to align regulatory plans with development strategies.
• Support interactions, reviews, and submissions with regulatory authorities.
• Assess regulatory intelligence to inform strategy and decision-making.
• Ensure compliance with global, regional, and local regulatory requirements through the product lifecycle.
• Drive process improvements, innovation, and performance excellence.

Conhecimentos

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Pharmaceutical Regulatory Compliance

Regulatory Strategies

Resource Management

Stakeholder Management

Formação académica

Bachelor's degree in biological, pharmaceutical or healthcare science

Advanced scientific degree (PhD, MD, PharmD)

Descrição da oferta de emprego

GSK is seeking a Global Regulatory Affairs Manager in Oncology to develop and execute regulatory strategies across global and regional markets, ensuring optimal labeling and approvals while staying compliant with regulatory standards. You will collaborate with GRL and TA heads and engage cross-functional teams to shape development plans and regulatory interactions.

The role is based at GSK HQ in London or Stevenage, with options in Switzerland or Belgium, and offers a hybrid work pattern.