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.