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- Tasks: Shape strategic regulatory initiatives and influence policy for innovative medicines.
- Company: Leading global biopharmaceutical organisation focused on advancing science and patient care.
- Benefits: Autonomy, collaboration, and opportunities for personal growth and development.
- Why this job: Make a real impact on patient outcomes in a mission-driven environment.
- Qualifications: Strong UK regulatory background and experience managing submissions post-Brexit.
- Other info: Opportunity to influence national regulatory strategy and drive meaningful change.
The predicted salary is between 36000 - 60000 £ per year.
Our client, a leading global biopharmaceutical organisation, is dedicated to advancing science and improving patient lives. With people at the heart of every decision, they are committed to ensuring patients today and for generations to come receive the treatments they need.
We are supporting them in the search for an exceptional Regulatory Affairs Specialist to join their UK organisation and play a pivotal role in shaping strategic regulatory initiatives.
As a Regulatory Partner, you will be a key member of the UK Regulatory function, providing expert guidance and strategic direction across a broad portfolio. You will collaborate cross-functionally to influence policy, accelerate access to innovative medicines, and ensure the company maintains a strong licence to operate in the UK.
This is a unique chance to make a tangible impact on patient outcomes within a mission driven, science led environment.
Working within the UK Regulatory Group, you will:
- Navigate and translate evolving UK regulatory requirements into business ready solutions.
- Lead or support Clinical Trial Applications, National Licensing Applications, Early Access to Medicines submissions, and national components of centralised EU procedures.
- Act as a primary point of contact with the MHRA, representing the organisation externally with credibility and influence.
- Partner with internal teams at both local and global levels to shape strategy and maintain compliance.
- Identify opportunities within a shifting regulatory landscape and support continuous improvement.
What you will need to succeed:
- A passionate regulatory professional with a strong UK regulatory background and a desire to contribute to better patient outcomes.
- A scientific degree (or equivalent experience).
- Extensive experience in UK Regulatory Affairs.
- Proven experience managing UK submissions in the post-Brexit environment.
- Strong knowledge of UK and EU regulatory processes.
- Experience providing strategic and technical regulatory advice.
- A track record of developing and delivering regulatory strategies.
- Excellent documentation and submission quality skills.
- Experience as a Subject Matter Expert (SME) in relevant therapeutic or regulatory areas.
- Confidence in mentoring peers and managing cross-functional stakeholder relationships.
What you will get in return:
- Places patients at the centre of everything they do.
- Encourages autonomy, collaboration, and innovation.
- Invests in the growth and development of its people.
- Offers the chance to influence national regulatory strategy and drive meaningful change across the UK healthcare ecosystem.
If you are interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn’t quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Regulatory Affairs Manager UK and Ireland in Welwyn Garden City employer: Hays
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Manager UK and Ireland in Welwyn Garden City
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK regulatory processes and recent changes. We recommend practising common interview questions with a friend to boost your confidence and ensure you shine during the real deal.
✨Tip Number 3
Showcase your expertise! During interviews, share specific examples of how you've navigated complex regulatory challenges. We want to see your problem-solving skills in action, so don’t hold back!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate candidates who want to make a difference in patient outcomes.
We think you need these skills to ace Regulatory Affairs Manager UK and Ireland in Welwyn Garden City
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that align with the Regulatory Affairs Manager role. Highlight your UK regulatory background and any relevant achievements to catch our eye!
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 better patient outcomes. Keep it concise but impactful!
Showcase Your Expertise: Don’t shy away from detailing your experience with UK submissions and regulatory processes. We want to see your track record of success, so be specific about your contributions and results.
Apply Through Our Website: We encourage you to apply directly through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves!
How to prepare for a job interview at Hays
✨Know Your Regulatory Stuff
Make sure you brush up on the latest UK regulatory requirements and how they impact biopharma. Be ready to discuss specific examples of how you've navigated these regulations in your past roles.
✨Showcase Your Strategic Thinking
Prepare to talk about how you've developed and delivered regulatory strategies in the past. Think of concrete examples where your strategic input made a difference, especially in a post-Brexit context.
✨Demonstrate Cross-Functional Collaboration
Since this role involves working with various teams, be ready to share experiences where you've successfully partnered with others. Highlight your ability to influence policy and drive initiatives across departments.
✨Be Patient-Centric
Remember, the company is all about improving patient outcomes. Frame your answers to reflect how your work in regulatory affairs has positively impacted patients, showing that you align with their mission.
