Associate Director, Global Regulatory Strategy – GRS

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Formulate and execute a global/regional regulatory strategy for designated assets in accordance with the Medicines Development Strategy and Integrated Asset Plan.

• Collaborate closely with Early/Medicine Development Teams (EDT/MDT) or the Global Regulatory Lead (GRL) to ensure the formation of robust regulatory strategies that satisfy key market demands.

• Oversee interactions, reviews, and submissions with regional/local regulatory authorities regarding product development and approval processes.

• Partner with commercial teams within the local region to achieve optimal labeling based on available data.

• Evaluate regulatory intelligence, precedents, and the competitive landscape to inform strategy formulation and enhance decision-making.

• Ensure adherence to global, regional, and local regulatory standards throughout the product lifecycle.

• Build strong collaborative relationships within GSK (up to VP level) and promote dialogue across teams to enhance outcomes.

• Propel process improvements, innovation, and performance excellence by developing and executing strategic changes.

⛳️ Requirements

• Minimum: Bachelor’s degree in Biological or Healthcare Science.

• Background in all stages of the drug development process, ideally in regulatory affairs.

• Proven experience in Oncology Global Regulatory Affairs with expertise in leading global and regional development, submission, and approval initiatives.

• Extensive knowledge of clinical trial and licensing regulations across major regional/global markets.

• Capability to devise innovative and compliant solutions to regulatory challenges while meeting agency expectations.

• Excellent communication skills, especially in writing, ensuring clarity and impact.

🏝️ Benefits

• Opportunities for professional development.