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

Santen; Greater London; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global healthcare company is seeking an experienced EMEA Regional Regulatory Lead to drive regulatory strategies for product development in Europe, the Middle East, and Africa. This role requires extensive experience in medicinal Regulatory Affairs, with a strong focus on UK and European regulations. Responsibilities include managing regulatory submissions, collaborating with stakeholders, and ensuring compliance with regional authorities. Ideal candidates should possess excellent communication skills and the ability to navigate complex regulatory environments. The company promotes a flexible and inclusive work environment.

Qualifications

• At least 8 years of experience in Regulatory Affairs in Europe and the UK.
• Strong expertise in EMEA regulatory agencies.
• Proven experience in negotiating with regulatory authorities.
• Deep knowledge of regulatory guidelines and industry best practices.
• Ability to communicate complex regulatory frameworks clearly.

Responsibilities

• Lead the development and implementation of EMEA regulatory strategies.
• Manage affiliate-level Regulatory Affairs activities for the UK & Ireland.
• Build relationships with regulatory stakeholders in EMEA.
• Conduct regulatory intelligence activities.
• Prepare and coordinate Product Information.

Skills

Medicinal Regulatory Affairs experience

Navigating MHRA and HPRA

Designing regulatory strategies

Knowledge of medicinal legislation

Excellent communication in English

Job description

Job Description

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.

Qualifications

What You Will Bring to the Role

• 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 across the product lifecycle.
• Strong expertise navigating 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.

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of “Happiness with Vision” by providing eye health products and services to patients, consumers, and medical professionals around the world. Guided by our CORE PRINCIPLE, “Tenki ni sanyo suru”, Santen is engaged in the global research & development, manufacturing, and sales and marketing of pharmaceutical products in ophthalmology. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.