The Company
A global, science-led pharmaceutical organization with a long-established heritage and a focused commitment to eye health. The company operates across multiple global regions and is dedicated to developing innovative ophthalmic therapies that improve patient outcomes. Its mission is to deliver meaningful value to patients and healthcare systems through scientific expertise and a patient-centric approach.
The Role
We are seeking an experienced EMEA Regional Regulatory Lead to define and execute regulatory strategies supporting the development and registration of pharmaceutical pipeline products 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 evolving regulatory landscapes, and enable successful development and approvals across the EMEA region. You will also support affiliate-level regulatory activities for selected countries within the region.
Key Responsibilities
- Lead EMEA regulatory strategy development for pipeline development programmes, aligned with global regulatory plans
- Represent the EMEA region in global regulatory teams, providing strategic and regional input
- Own regional regulatory strategy across the product lifecycle
- Oversee selected affiliate regulatory activities, including authority interactions and country-specific submission strategies
- Build and maintain relationships with regulatory authorities across EMEA (e.g., EMA, MHRA, HPRA)
- Conduct regulatory intelligence and competitor/landscape monitoring to support risk and opportunity planning
- Monitor changes in regulatory frameworks and assess impact on development and lifecycle strategies
- Prepare and coordinate product information (SmPCs, labelling, PILs) with cross-functional teams
- Review promotional and packaging materials for regulatory compliance
- Support regulatory SOPs, lifecycle management, and cross-functional regulatory deliverables
Requirements
- 8+ years of experience in medicinal regulatory affairs in Europe/UK
- Proven experience in regulatory strategy, submissions, and lifecycle management
- Strong experience interacting with EMA, MHRA, HPRA and other authorities
- Experience in Marketing Authorization Applications and clinical development support
- Strong understanding of EU/UK regulatory frameworks and legislation
- Ability to influence and communicate across global matrix organizations
- Strong stakeholder management and cross-functional collaboration skills
- Excellent written and verbal English
- High adaptability and ability to operate in global environments
Interested in this position? Apply now!
✉ caustin@barringtonjames.com
☎ +44 (0) 1293 77664
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