About the job
As the EMEA Regional Regulatory Lead at Santen, you will be pivotal in shaping and executing regulatory strategies that facilitate the development and registration of our pharmaceutical pipeline projects across Europe, the Middle East, and Africa. Your role as a key regulatory expert will involve collaborating with global, regional, and local stakeholders to ensure compliance, foresee market and legislative shifts, and drive successful regulatory strategies throughout the EMEA region. Additionally, you will serve as the UK/IE Cluster Lead, overseeing local regulatory activities for our product portfolio in the UK and Ireland.
Key Responsibilities
Lead the creation and execution of EMEA regulatory strategies aligned with global regulatory plans, tailoring regional approaches as necessary.
Represent EMEA in Global Regulatory Sub-teams (RST), providing insights on regional nuances, commercial considerations, and strategic recommendations for global product plans.
Own the regulatory strategy for assigned projects, ensuring comprehensive and effective management.
Oversee all affiliate-level Regulatory Affairs activities in the UK & Ireland, including liaising with local authorities, advising management on regulatory matters, and optimizing submission strategies.
Foster and sustain strong relationships with regulatory stakeholders across the EMEA region, particularly with EMA, MHRA, and HPRA, representing Santen in meetings, industry interactions, and consultations.
Conduct regulatory intelligence, including competitor label analysis and identifying emerging trends to proactively develop strategies for mitigation or opportunity.
Monitor and anticipate changes in the EMEA regulatory landscape to refine development strategies, contributing to risk assessments and strategic planning.
Prepare, review, and coordinate Product Information, ensuring alignment with approved texts in collaboration with Pharmacovigilance, Medical Affairs, and other departments.
Review promotional materials and secondary packaging for regulatory compliance, maintain regulatory SOPs, support pricing and reimbursement efforts, ensure adherence to GDP guidelines, and carry out additional tasks as directed by regulatory leadership.

