At a Glance
- Tasks: Lead regulatory strategies for innovative pharmaceutical products across EMEA.
- Company: Global science-led pharmaceutical organisation focused on eye health.
- Benefits: Competitive salary, career growth, and a chance to impact patient outcomes.
- Other info: Dynamic role with opportunities to influence global regulatory strategies.
- Why this job: Join a mission-driven team making a difference in healthcare through innovation.
- Qualifications: 8+ years in regulatory affairs with strong EU/UK experience.
The predicted salary is between 70000 - 90000 € per year.
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.
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!
Associate Director Regulatory Affairs in City of London employer: Barrington James
As a global leader in the pharmaceutical industry, this company offers an exceptional work environment for professionals in Regulatory Affairs, particularly in the vibrant EMEA region. With a strong commitment to innovation and patient-centric solutions, employees benefit from a collaborative culture that fosters professional growth and development, alongside competitive remuneration and comprehensive benefits. The opportunity to engage with regulatory authorities and contribute to groundbreaking ophthalmic therapies makes this role both meaningful and rewarding.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director Regulatory Affairs in City of London
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field, especially those who have experience with EMEA regulations. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU/UK regulatory frameworks. Be ready to discuss how you've navigated complex regulatory landscapes in the past. Show us that you can think strategically and adapt to changes in regulations!
✨Tip Number 3
Don’t just apply anywhere—focus on companies that align with your values and expertise. When you find a role that excites you, apply through our website to ensure your application gets the attention it deserves!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Use this opportunity to reiterate your enthusiasm for the role and how your experience aligns with their needs.
We think you need these skills to ace Associate Director Regulatory Affairs in City of London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Associate Director Regulatory Affairs. 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’re looking for someone who can navigate complex environments and influence across global teams, so make sure to highlight relevant examples.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications better and ensures you don’t miss out on any important updates. Plus, it’s super easy – just a few clicks and you’re done!
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 and how they might impact the company's pipeline will show that you're not just knowledgeable but also proactive.
✨Showcase Your Stakeholder Skills
Prepare examples of how you've successfully managed relationships with regulatory authorities like 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 about how you would handle specific regulatory challenges or changes in the landscape. Think through potential scenarios beforehand, so you can articulate your strategic thinking and problem-solving skills clearly.
✨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.
