Senior Regulatory Lead

We are seeking a Regulatory leader to head a small and dynamic regulatory group. The role is a mix of development, LCM and strategy.

Key Responsibilities

• Manage regulatory activities related to mature products across multiple global markets, ensuring compliance with local regulations
• Prepare, submit, and maintain variations, renewals, labelling updates, and CMC (Chemistry, Manufacturing & Controls) dossiers.
• Liaise with global health authorities and internal stakeholders to ensure timely approvals and regulatory compliance.
• Develop and execute regulatory strategies for MAA and lifecycle management, identifying opportunities for process improvements.
• Lead and mentor a small team of regulatory professionals, providing guidance, training, and performance management.
• Maintain up-to-date knowledge of regulatory guidelines and requirements, ensuring best practices are followed.
• Collaborate with cross-functional teams, including Quality, Supply Chain, and Commercial teams, to support business objectives.

Key Requirements

• Experience in Regulatory Affairs within the pharmaceutical industry.
• Strong knowledge of EU regulatory requirements (MRP, DCP, NP).
• Small molecule expertise
• MDR understanding
• Experience with CMC, variations, renewals, and labelling updates.
• Excellent communication and stakeholder management skills.
• Ability to work effectively in a fast-paced, collaborative environment.