EMEA Regulatory Lead & UK/Ireland Cluster Strategist

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

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.