Senior EMEA Regulatory Lead – UK & Ireland Cluster

As the EMEA Regional Regulatory Lead, you will prepare, drive and execute regulatory strategies supporting the development and registration of Santen’s pharma pipeline development projects across Europe, the Middle East, and Africa. You will act as a key regional regulatory expert, partnering with global, regional, and local stakeholders to ensure regulatory compliance, anticipate market and legislative trends, and enable successful regulatory product strategies throughout the EMEA region. Additionally, you will act as UK/IE Cluster Lead managing local affiliate-level regulatory activities in UK and Ireland for Santen's product portfolio there.

What You Will Do

• Lead the development and implementation of EMEA regulatory strategies for pharma pipeline project, 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 assigned projects.
• 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 EMA, 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.

Qualifications

• At least 8 years of experience in medicinal Regulatory Affairs within Europe and the UK, with a track record of developing, submitting, and managing regulatory submissions for pipeline development projects.
• Strong expertise navigating EMA, MHRA, HPRA, and other EMEA regulatory agencies, with demonstrated ability to negotiate, influence, and build trust‑based relationships with authorities.
• Proven experience designing regulatory strategies for development assets across EMEA, including understanding of inter-regional submission considerations and lifecycle management.
• Deep knowledge of medicinal legislation, regulatory guidelines, and industry best practices across Europe, the UK, and the broader EMEA region, including multi‑country regulatory requirements.
• Expert command of Marketing Authorisation Applications and other regulatory submissions, from early planning through post‑submission interactions and approvals.
• Ability to interpret, translate, and communicate complex regulatory frameworks and guidance clearly to cross‑functional stakeholders from local, regional, and global teams.
• Strong collaboration abilities, contributing to knowledge‑sharing forums, alignment discussions, cross‑functional decision‑making, and joint strategy development with GRLs and other RRLs.
• Excellent communication skills in English, both written and spoken, with the capability to interface effectively with senior leadership, scientific teams, and external regulatory stakeholders.
• High adaptability and cultural awareness, enabling effective collaboration in a diverse regional and global environment while proactively driving teamwork and continuous improvement.