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- Tasks: Lead UK regulatory strategy for innovative drugs and ensure compliance with evolving regulations.
- Company: Join a leading pharmaceutical business with a focus on growth and innovation.
- Benefits: Competitive salary, car allowance, bonus, private healthcare, and flexible benefits.
- Why this job: Make a real impact in the pharmaceutical industry while developing your career.
- Qualifications: University degree in a scientific subject and 5+ years of UK Regulatory Affairs experience.
- Other info: Extensive opportunities for growth and development within a dynamic environment.
The predicted salary is between 65000 - 75000 £ per year.
This is an excellent opportunity to join a leading pharmaceutical business. In this position, you will be responsible for all aspects of the UK product portfolio for developing drugs and established products. You will work as a subject matter expert within the UK affiliates and support both new registrations and lifecycle maintenance. The Regulatory group works with the wider business to translate the constantly evolving requirements of the UK Regulatory environment into the business's policies, procedures, solutions and strategies that ensure compliance and maximise the value for patients.
Role responsibilities:
- Support the team in ensuring that regulatory requirements are met for Clinical Trial Applications.
- Lead all interactions with the MHRA, including Scientific Advice, PIPS, and pre-submission meetings.
- Drive end-to-end UK regulatory strategy for innovative developing drugs.
- Clinical Trial Applications, National Licensing Applications, Early Access to Medicines Applications, and National components of medicines authorisation via the European Centralised procedure.
- Support the teams in any interaction with the MHRA.
- Provide regulatory expertise on new product development.
- Support MAA's filling into the UK market.
Requirements:
- University degree in a scientific subject.
- At least 5 years of prior UK-related RA experience.
- Extensive experience in UK Regulatory Affairs.
- Proven experience managing UK submissions post-Brexit.
- Experience providing strategic and technical advice.
- In-depth knowledge and experience of UK and EU regulatory requirements and procedures.
- A proven track record of developing, implementing, and communicating regulatory strategies.
- Excellent documentation skills to ensure high-quality and timely submissions.
- Experience as a Subject Matter Expert (SME) in defined subject areas or therapeutic areas.
- Experience in mentoring peers, as well as managing stakeholder relationships.
Due to the organisation's rapid growth, there is extensive opportunity to grow and develop within the company. In addition to a competitive salary, the organisation offers a highly attractive benefits package that includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements.
If you are interested in this role or would like more details, please email your CV to lucy.kirkaldy@cpl.com.
UK Regulatory Affairs Manager in Letchworth employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land UK Regulatory Affairs Manager in Letchworth
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can help you connect with the right people who might just have the inside scoop on job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK regulatory requirements and recent changes. We suggest practising common interview questions with a friend or using mock interview tools to boost your confidence.
✨Tip Number 3
Showcase your expertise! During interviews, be ready to discuss specific examples of how you've navigated regulatory challenges. We believe that sharing your success stories can really set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we often have exclusive roles listed that you won’t find anywhere else.
We think you need these skills to ace UK Regulatory Affairs Manager in Letchworth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your relevant experience in UK regulatory submissions and any specific projects that align with the job description. We want to see how your background fits perfectly with what we’re looking for!
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 your expertise can benefit our team. Keep it concise but impactful, and don’t forget to mention your experience with the MHRA and post-Brexit submissions.
Showcase Your Documentation Skills: Since excellent documentation skills are crucial for this role, make sure to highlight any relevant experiences where you’ve successfully managed submissions or developed regulatory strategies. We love seeing examples of high-quality work!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on the latest UK and EU regulatory requirements. Being able to discuss recent changes or trends in the regulatory landscape will show that you're not just knowledgeable but also passionate about the field.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully managed submissions or interacted with the MHRA. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your achievements.
✨Demonstrate Strategic Thinking
Be ready to discuss how you would approach developing regulatory strategies for innovative drugs. Think about potential challenges and how you would overcome them, as this will demonstrate your ability to think critically and strategically.
✨Engage with Questions
Prepare thoughtful questions to ask at the end of the interview. This could be about the company's future projects or how they navigate regulatory changes. It shows your interest in the role and helps you assess if the company is the right fit for you.
