UK Regulatory Affairs Manager
UK Regulatory Affairs Manager

UK Regulatory Affairs Manager

Full-Time 36000 - 60000 Β£ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Lead UK regulatory strategy for innovative drugs and ensure compliance with evolving regulations.
  • 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 developing your career.
  • Qualifications: University degree in a scientific subject and 5+ years of UK Regulatory Affairs experience.
  • Other info: Dynamic environment with extensive opportunities for personal and professional growth.

The predicted salary is between 36000 - 60000 Β£ 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.
  • 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 employer: Cpl Life Sciences

Join a leading pharmaceutical business in Hertfordshire as a UK Regulatory Affairs Manager, where you will thrive in a dynamic and supportive work culture that prioritises employee growth and development. With a competitive salary and an attractive benefits package including private healthcare and a flexible benefits scheme, this role offers the chance to make a meaningful impact on patient care while collaborating with experts in the field. Embrace the opportunity to lead regulatory strategies and enhance your career in a rapidly growing organisation committed to compliance and innovation.
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Contact Detail:

Cpl Life Sciences Recruiting Team

StudySmarter Expert Advice 🀫

We think this is how you could land UK Regulatory Affairs Manager

✨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 and expertise in the field.

✨Tip Number 3

Don’t just apply anywhere; focus on companies that align with your values and career goals. We suggest using our website to find roles that excite you and match your skills, making your application stand out.

✨Tip Number 4

Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role. We believe this small gesture can keep you top of mind for hiring managers.

We think you need these skills to ace UK Regulatory Affairs Manager

Regulatory Affairs
Clinical Trial Applications
MHRA Interaction
UK Regulatory Strategy
National Licensing Applications
Early Access to Medicines Applications
Scientific Advice
Documentation Skills
Stakeholder Management
Subject Matter Expert (SME)
Strategic and Technical Advice
Knowledge of UK and EU Regulatory Requirements
Mentoring Skills
Problem-Solving Skills

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 affairs 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!

Showcase Your Expertise: Don’t hold back on showcasing your expertise! If you’ve got experience with MHRA interactions or developing regulatory strategies, make it shine in your application. We love seeing candidates who can demonstrate their knowledge and skills clearly.

Keep It Professional Yet Personal: While we appreciate professionalism, don’t be afraid to let your personality come through in your application. A touch of authenticity can make you stand out. We’re looking for someone who not only meets the qualifications but also fits into our team culture.

Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications better and ensures you don’t miss out on any important updates. Plus, it’s super easy to do!

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 prepare for questions about your experience with Scientific Advice and pre-submission meetings. Think of examples from your past roles where you successfully navigated these processes.

✨Showcase Your Strategic Thinking

Be ready to discuss how you've developed and implemented regulatory strategies in previous positions. Use specific examples to illustrate your thought process and how your strategies maximised value for patients and ensured compliance.

✨Highlight Your Mentoring Skills

This role involves mentoring peers, so come prepared to talk about your experience in this area. Share stories that demonstrate your ability to manage stakeholder relationships and support team members in their professional growth.

UK Regulatory Affairs Manager
Cpl Life Sciences
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