Regional Regulatory Strategist- Oncology
Location: UK (Hybrid)
Industry: Global Biopharmaceutical Company
A leading global biopharma organisation is seeking a Regional Regulatory Strategist to support its oncology portfolio. This UK-based role focuses on shaping and delivering regulatory strategy for the European region, working closely with global and regional stakeholders.
Responsibilities:
• Lead UK and EU regional regulatory strategy across assigned oncology products
• Provide regional input into global regulatory plans, labelling and risk assessments
• Manage regional Health Authority interactions and support regulatory submissions
• Ensure high-quality delivery of CTAs, MAAs, variations and lifecycle updates
• Monitor emerging regulatory guidelines and ensure compliance across the portfolio
• Collaborate with cross-functional teams including clinical, safety, manufacturing and commercial
Ideal Background:
• Scientific degree
• Strong UK and EU regulatory affairs experience within drug development
• Experience preparing and submitting CTAs, MAAs or variations
• Familiarity engaging with MHRA and ideally EMA
• Knowledge of oncology is an advantage but not essential
• Strong communication, stakeholder engagement and regulatory strategy skills