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- Tasks: Lead UK regulatory strategy and ensure compliance for innovative drug development.
- Company: Join a leading pharmaceutical company with a focus on growth and innovation.
- Benefits: Competitive salary, flexible benefits, private healthcare, and share ownership scheme.
- Why this job: Make a real impact in the pharmaceutical industry while advancing your career.
- Qualifications: 5+ years in UK Regulatory Affairs and a scientific degree required.
- Other info: Dynamic environment with extensive opportunities for personal and professional growth.
The predicted salary is between 36000 - 60000 £ 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.
- University degree in a scientific subject.
- At least 5 years of prior UK-related RA experience.
- Extensive experience in UK Regulatory Affairs.
- 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.
UK Regulatory Affairs Manager in London 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 London
✨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 requirements. We recommend practising common interview questions and having examples ready that showcase your experience with Clinical Trial Applications and interactions with the MHRA.
✨Tip Number 3
Showcase your expertise! During interviews, highlight your experience as a Subject Matter Expert and how you’ve successfully navigated regulatory strategies. We want to see how you can bring value to the team!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace UK Regulatory Affairs Manager in London
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 processes and any specific achievements that align with the job description.
Showcase Your Expertise: Don’t shy away from showcasing your expertise in UK and EU regulatory requirements. Use specific examples to demonstrate how you've successfully navigated these regulations in your previous roles.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your background makes you the perfect fit for our team at StudySmarter.
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!
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 specific regulations and how they impact drug development will show that you're not just familiar with the basics, but that you’re a true expert in your field.
✨Prepare for MHRA Interactions
Since you'll be leading interactions with the MHRA, it’s crucial to understand their processes and expectations. Familiarise yourself with previous Scientific Advice and PIPS meetings to demonstrate your proactive approach and readiness to engage effectively.
✨Showcase Your Strategic Thinking
Be ready to discuss how you've developed and implemented regulatory strategies in the past. Use specific examples to illustrate your ability to navigate complex regulatory landscapes and drive successful outcomes for innovative drugs.
✨Highlight Your Mentoring Skills
This role involves mentoring peers, so think about times when you've supported others in their professional growth. Share these experiences to show that you can foster a collaborative environment and build strong stakeholder relationships.
