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

SantenLondon
On-site Full-time

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Experience Level

Experience

Qualifications

What You Will Bring to the RoleMinimum of 8 years of experience in medicinal Regulatory Affairs within Europe and the UK, with a proven record in developing, submitting, and managing regulatory submissions for pipeline projects. In-depth expertise with EMA, MHRA, HPRA, and other EMEA regulatory agencies, demonstrating ability to negotiate, influence, and establish trust-based relationships with authorities. Experience in designing regulatory strategies for development assets across EMEA, including knowledge of inter-regional submission considerations and lifecycle management. Comprehensive understanding of medicinal legislation, regulatory guidelines, and industry best practices throughout Europe, the UK, and the broader EMEA region, including multi-country regulatory requirements. Proficient with Marketing Authorisation Applications and other regulatory submissions, from early planning through to execution.

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.

About Santen

Santen is a dedicated company with a rich 130-year history, exclusively focused on eye health. Originating from Japan, we operate globally in over 60 countries and regions, committed to delivering essential value to patients and society through our specialized products and services, shaped by our expertise in ophthalmology and the perspectives of our patients.

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