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- Tasks: Manage regulatory submissions and ensure compliance for innovative dermatology products.
- Company: LEO Pharma, a global leader in medical dermatology with 117 years of innovation.
- Benefits: Hybrid working options, collaborative culture, and opportunities for professional growth.
- Why this job: Make a real impact on patient care and work with cutting-edge healthcare solutions.
- Qualifications: Experience in Regulatory Affairs and a degree in pharmacy or life sciences.
- Other info: Join a diverse team dedicated to driving change and improving lives.
The predicted salary is between 36000 - 60000 £ per year.
LEO Pharma is looking for an experienced Regulatory Affairs professional to join our UK & Ireland team in a pivotal role ensuring our dermatology and rare disease portfolio reaches patients safely and in compliance with all regulatory requirements. If you’re ready to take the next step in your career and make an impact, this is the opportunity for you!
At LEO Pharma, we are global leaders in medical dermatology. We have 117 years’ experience in bringing innovation to healthcare. Each year, close to 100 million people have a better day because of our medicines. In the Regulatory Affairs team, we share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.
The ideal candidate will be able to work collaboratively as part of both a local and global team.
Your Role
As Regulatory Affairs Manager UKIE at LEO Pharma, you will work across the full product lifecycle, from clinical development to marketing authorisations - influencing strategy and delivering submissions that make a genuine difference. In this role, you will be the local regulatory point of contact for both the UK (MHRA) and Ireland (HPRA), managing a diverse portfolio, including our pipeline and innovative products across dermatology and rare disease. You’ll provide strategic local input into global drug development, lead complex regulatory submissions, and maintain excellent relationships with authorities and trade associations. This role is based at our Head Office in Maidenhead, with the option for hybrid working.
Key Responsibilities
- Securing and maintaining clinical trial and marketing authorisations for LEO Pharma products in the UK & Ireland.
- Providing strategic regulatory input from the local market to global development projects.
- Managing high‑complexity submissions under tight timelines.
- Maintaining regulatory databases and ensuring documentation accuracy.
- Representing Regulatory Affairs in global and external meetings.
- Establishing and developing effective relationships with MHRA, HPRA, EMA, and industry associations.
Your Qualifications
- Professional fluency in English.
- Degree in pharmacy, life sciences, or equivalent by experience.
- Significant Regulatory Affairs experience within the pharmaceutical industry, ideally across both clinical and marketing authorisations.
- Dermatology and/or rare disease experience would be advantageous.
- Experience of providing strategic local regulatory input to global drug development.
- Proficiency with regulatory systems/workflows and document approval tools.
- Excellent project management skills and ability to work effectively within a dynamic environment.
- Comprehensive knowledge of UK/Ireland regulatory frameworks and procedures.
- Experience in maintaining regulatory databases.
- Prior experience of partnering with local and global teams, and industry stakeholders.
LEO Pharma is built on collaboration, innovation and curiosity. Is this you?
Your Application
You do not need to upload a cover letter, but feel free to add a few sentences in your CV on why this position has your interest.
Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.
For certain positions, LEO Pharma might complete a background check conducted by a third party. Join us on our journey Beyond the Skin. Apply today!
Regulatory Affairs Manager UKIE in Maidenhead employer: レオ ファーマ株式会社
Contact Detail:
レオ ファーマ株式会社 Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager UKIE in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to current or former employees at LEO Pharma on LinkedIn. A friendly chat can give us insider info about the company culture and maybe even a referral!
✨Tip Number 2
Prepare for the interview by knowing your stuff! Brush up on regulatory frameworks in the UK and Ireland, and be ready to discuss how your experience aligns with LEO Pharma's mission in dermatology and rare diseases.
✨Tip Number 3
Show off your project management skills! Be ready to share examples of how you've successfully managed complex submissions under tight deadlines. We want to see how you handle pressure!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at LEO Pharma.
We think you need these skills to ace Regulatory Affairs Manager UKIE in Maidenhead
Some tips for your application 🫡
Show Your Passion: When you're filling out your application, let your enthusiasm for the role shine through! Mention why you're excited about working in Regulatory Affairs at LEO Pharma and how you can contribute to our mission of making a difference in patients' lives.
Tailor Your CV: Make sure your CV is tailored to highlight your relevant experience in Regulatory Affairs. Focus on your achievements in managing submissions and your knowledge of UK/Ireland regulatory frameworks. We want to see how your background aligns with what we're looking for!
Keep It Clear and Concise: While we love detail, clarity is key! Use straightforward language and bullet points to make your CV easy to read. This helps us quickly spot your qualifications and understand your journey in the pharmaceutical industry.
Apply Through Our Website: Don't forget to apply through our website! It's the best way to ensure your application gets to us directly. Plus, it shows you're serious about joining our team at LEO Pharma. We can't wait to hear from you!
How to prepare for a job interview at レオ ファーマ株式会社
✨Know Your Regulatory Stuff
Make sure you brush up on the UK and Ireland regulatory frameworks, especially those related to dermatology and rare diseases. Being able to discuss specific regulations and how they impact product lifecycles will show that you're not just familiar with the basics but are genuinely invested in the role.
✨Showcase Your Collaboration Skills
LEO Pharma values collaboration, so be ready to share examples of how you've worked effectively within teams, both locally and globally. Highlight any experiences where you’ve successfully partnered with regulatory authorities or industry stakeholders to achieve common goals.
✨Prepare for Complex Scenarios
Expect questions about managing high-complexity submissions under tight timelines. Think of specific instances where you’ve navigated challenges in regulatory submissions and be prepared to discuss your thought process and the outcomes.
✨Demonstrate Your Strategic Thinking
Since the role involves providing strategic input into global drug development, come prepared with insights on how local market needs can influence global strategies. Discuss any past experiences where your input made a significant difference in project outcomes.
