[UK] Associate Director, EMEA Regional Regulatory Lead & UK/IE Cluster Lead

As the EMEA Regional Regulatory Lead, you will drive and execute regulatory strategies supporting the development, registration, commercialization, and lifecycle management of Santen’s products across Europe, the Middle East, and Africa. You will act as a key regional regulatory expert, partnering with global, regional, and local stakeholders—including UK and Ireland affiliates—to ensure regulatory compliance, anticipate market and legislative trends, and enable successful product strategies throughout the EMEA region.

What You Will Do

• Lead the development and implementation of EMEA regulatory strategies for pipeline, multi-regional, and established products, ensuring alignment with global regulatory plans (GRP) and adapting regional approaches when required.

• Act as the EMEA representative within Global Regulatory Sub-teams (RST), providing regional insights, commercial considerations, and strategic input into global product plans.

• Take ownership of regulatory strategy for regional or established products without a Global Regulatory Lead, coordinating global regulatory activities and acting as GRL when needed.

• Manage all affiliate-level Regulatory Affairs activities for the UK & Ireland, including interactions with local authorities, advising country management on regulatory topics, and ensuring optimal country-specific submission strategies.

• Build and maintain strong relationships with regulatory stakeholders in EMEA—particularly MHRA and HPRA—representing Santen in agency meetings, industry interactions, and regulatory consultations.

• Conduct regulatory intelligence activities, including competitor label analysis, identification of emerging regulatory trends, and proactive development of mitigation or opportunity-driven strategies.

• Monitor and anticipate changes in the EMEA regulatory and market landscape to refine development strategies, contributing to risk assessments, opportunity identification, and strategic scenario planning.

• Prepare, review, and coordinate Product Information—including SmPCs, patient leaflets, labelling, and CCDS—ensuring alignment with approved texts and partnering closely with PV, Medical Affairs, and other functions.

• Review promotional materials and secondary packaging for regulatory compliance, maintain regulatory SOPs and work instructions, support pricing and reimbursement activities, ensure adherence to GDP guidelines, and perform any additional tasks assigned by regulatory leadership.