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, health benefits, and opportunities for professional growth.
- Other info: Join a dynamic team dedicated to innovation and patient-centric solutions.
- Why this job: Make a real impact in patient outcomes through regulatory expertise.
- Qualifications: 8+ years in medicinal regulatory affairs with strong stakeholder management skills.
The predicted salary is between 60000 - 80000 £ 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.
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.
- 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
- 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
- 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
- Experience in Marketing Authorization Applications and clinical development support
- Strong understanding of EU/UK regulatory frameworks and legislation
- Strong stakeholder management and cross-functional collaboration skills
- Excellent written and verbal English
Associate/Associate Director Planning in London employer: Barrington James
As a global leader in the pharmaceutical industry, our company offers a dynamic and inclusive work environment that prioritises employee growth and development. With a strong commitment to eye health and innovative therapies, we provide our team members with unique opportunities to engage in meaningful work that directly impacts patient outcomes across the EMEA region. Our collaborative culture fosters strong relationships with regulatory authorities and encourages continuous learning, making us an excellent employer for those seeking to advance their careers in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Associate/Associate Director Planning in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical industry, especially those with experience in regulatory affairs. 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 your experience aligns with the company's mission and values. Show them you're not just a fit for the role, but also for their culture!
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email expressing your appreciation for the opportunity. It’s a great way to reinforce your interest in the position and keep you top of mind.
✨Tip Number 4
Apply directly through our website! We love seeing candidates who take the initiative. Plus, it shows your genuine interest in joining our team and makes it easier for us to track your application.
We think you need these skills to ace Associate/Associate Director Planning in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Associate/Associate Director Planning. Highlight your experience in regulatory affairs and any specific achievements that align with the job description. We want to see how your background fits perfectly with our mission!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about eye health and how your skills can contribute to our innovative therapies. Keep it engaging and relevant to the role, showing us your personality and enthusiasm.
Showcase Your Regulatory Expertise:In your application, be sure to highlight your experience with regulatory strategy and submissions. We’re looking for someone who understands the EU/UK regulatory frameworks, so don’t hold back on sharing your knowledge and past successes in this area!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team at StudySmarter!
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 or cross-functional teams in the past. This role requires strong collaboration, so demonstrating your experience in this area will be key.
✨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 and have a structured approach ready to share during the interview.
✨Communicate Clearly and Confidently
Since excellent written and verbal English is a must, practice articulating your thoughts clearly. You might even want to rehearse common interview questions with a friend to ensure you come across as confident and articulate.
