At a Glance
- Tasks: Lead regulatory strategies for innovative ophthalmic therapies across Europe, the Middle East, and Africa.
- Company: Global pharmaceutical organisation focused on eye health and patient outcomes.
- Benefits: Competitive salary, professional development, and a chance to make a real impact.
- Other info: Dynamic role with opportunities for global collaboration and career growth.
- Why this job: Join a mission-driven team and shape the future of eye health therapies.
- Qualifications: 8+ years in regulatory affairs with strong EU/UK experience.
The predicted salary is between 70000 - 90000 £ per year.
The Company is 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 involves 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!
Associate Director Regulatory Affairs employer: Barrington James
As a global leader in the pharmaceutical industry, our company offers an exceptional work environment that prioritises innovation and patient-centric solutions. Employees benefit from a collaborative culture that fosters professional growth through continuous learning opportunities and engagement with diverse teams across the EMEA region. With a strong commitment to eye health and a focus on regulatory excellence, we provide a unique platform for individuals to make a meaningful impact in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Regulatory Affairs
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. Building connections can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU/UK regulatory frameworks. Be ready to discuss how your experience aligns with the company's mission and how you can contribute to their innovative ophthalmic therapies.
✨Tip Number 3
Showcase your stakeholder management skills! During interviews, share examples of how you've successfully collaborated with cross-functional teams and regulatory authorities. This will highlight your ability to navigate complex environments.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged with our company.
We think you need these skills to ace Associate Director Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Associate Director Regulatory Affairs role. Highlight your experience in regulatory strategy and submissions, especially within the EMEA region. We want to see how your background aligns with our mission in eye health!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our innovative ophthalmic therapies. Keep it concise but impactful – we love a good story!
Showcase Your Stakeholder Management Skills:In your application, emphasise your experience in managing relationships with regulatory authorities like EMA and MHRA. We value strong communication skills, so let us know how you've influenced decisions in a global matrix environment.
Apply Through Our Website:We encourage you to apply directly through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates. Plus, it shows you're keen on joining our team!
How to prepare for a job interview at Barrington James
✨Know Your Regulatory Stuff
Make sure you brush up on the latest EU/UK regulatory frameworks and legislation. Being able to discuss recent changes or trends in regulatory affairs will show that you're not just knowledgeable but also proactive about staying informed.
✨Showcase Your Stakeholder Skills
Prepare examples of how you've successfully managed relationships with regulatory authorities like the EMA or MHRA. Highlighting your experience in cross-functional collaboration will demonstrate your ability to influence and communicate effectively within a global matrix.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or changes in the landscape. Think through potential scenarios beforehand, so you can articulate your thought process and strategic approach clearly during the interview.
✨Prepare Your Questions
Have insightful questions ready about the company's regulatory strategies and how they align with their mission in eye health. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
