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- Tasks: Support regulatory compliance and pharmacovigilance in a fast-paced pharmaceutical environment.
- Company: Join Fresenius Medical Care, a global leader in dialysis services and medical devices.
- Benefits: Enjoy a competitive salary, 33 days holiday, health cash plan, and more perks.
- Why this job: Make a real impact on patient safety while working in a dynamic team culture.
- Qualifications: A degree in life sciences and experience with regulatory submissions are preferred.
- Other info: This hybrid role is based in Huthwaite, Nottinghamshire, with flexible working options.
The predicted salary is between 36000 - 60000 £ per year.
Regulatory Affairs Associate
Are you a detail-oriented professional with a strong background in regulatory affairs, and pharmacovigilance? Are you looking to make a real impact in a dynamic, fast-paced pharmaceutical environment?
We\’re seeking a Regulatory Affairs Associate to support our Regulatory Compliance Manager (RCM) in ensuring that our operations stay at the forefront of regulatory excellence and patient safety while also helping us drive forward best practices in compliance, product information, and pharmacovigilance.
This is a full-time role of 37.5 hours, working Monday to Friday, 9am – 5pm. This is a hybrid role, our head office based in Huthwaite, Nottinghamshire.
What does the role involve?
You will:
- Lead local pharmacovigilance (PV) activities, ensuring systems, reporting, and processes meet MHRA and GVP standards
- Support regulatory submissions (e.g. licence applications, product updates) and keep product information up to date
- Review promotional and non-promotional materials to ensure they comply with ABPI/IPHA codes
- Work closely with Marketing and internal teams to provide clear, compliant advice and guidance
- Deliver training on ABPI codes and PV requirements, and monitor compliance performance
About You, you will:
- A degree in a life science discipline (e.g., Pharmacy, Pharmacology, Chemistry, Biology, Nursing)
- Experience reviewing promotional materials under the ABPI Code
- Knowledge of GVP, MDR, Human Medicines Regulation, and medical device vigilance
- Excellent written and verbal communication skills
- A proactive, adaptable mindset with the ability to prioritise in a fast-changing environment
- Ideally have experience in regulatory submissions and medical device complaint handling (training can be provided)
What can we offer you?
Here at Fresenius Medical Care, we value the contribution of our people and ensure that we offer industry-leading rewards and progression.
We offer a competitive salary alongside a wealth of other fantastic benefits listed below:
- Company Pension Scheme
- Life Assurance
- 33 Days Holiday (inclusive of 8 days bank holiday) increasing with service
- Annual leave purchase scheme (with 12 months service)
- Company paid health cash plan
- Long Service Vouchers
- Cycle to Work Scheme
- bhsf RISE – our Health and Wellbeing hub 24/7 access to GP\’s and Counsellors
- Blue Light card – providing thousands of amazing discounts online and on the high street
Who is Fresenius Medical Care?
We are the leading provider of dialysis services to the NHS, operating 52 partnership dialysis units that together provide regular dialysis treatment to over 3,800 NHS patients in the UK. We are part of a global company treating over 344,000 patients worldwide across over 4,000 clinics.
We also operate 44 production sites on all continents to provide dialysis products such as dialysis machines, dialysers and related disposables. 1 in every 2 of all dialysis machines used around the globe are manufactured by Fresenius Medical Care and we are the 3rd largest medical devices company in the world.
Regulatory Affairs Assistant posts will be subject to a Basic DBS Disclosure
Fresenius Medical Care is an equal opportunities employer #J-18808-Ljbffr
Regulatory Affairs Specialist employer: Fresenius Medical Care
Contact Detail:
Fresenius Medical Care Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the specific regulations and guidelines relevant to the pharmaceutical industry, particularly those set by the MHRA and GVP. This knowledge will not only help you in interviews but also demonstrate your commitment to regulatory excellence.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with ABPI codes and pharmacovigilance. Attend industry events or join online forums to connect with others and gain insights that could give you an edge.
✨Tip Number 3
Prepare to discuss real-world examples of how you've ensured compliance in previous roles. Be ready to explain your thought process and the steps you took to address any challenges related to regulatory submissions or promotional materials.
✨Tip Number 4
Showcase your adaptability and proactive mindset during the interview. Share instances where you've successfully prioritised tasks in a fast-paced environment, as this is crucial for the dynamic nature of the role at Fresenius Medical Care.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs and pharmacovigilance. Use keywords from the job description to demonstrate that you meet the specific requirements of the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for regulatory affairs and your understanding of the pharmaceutical industry. Mention specific experiences that align with the responsibilities outlined in the job description.
Highlight Relevant Skills: In your application, emphasise your knowledge of GVP, MDR, and Human Medicines Regulation. Provide examples of how you've successfully navigated compliance issues or contributed to regulatory submissions in previous roles.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a Regulatory Affairs Specialist.
How to prepare for a job interview at Fresenius Medical Care
✨Know Your Regulations
Familiarise yourself with the key regulations and guidelines relevant to regulatory affairs, such as MHRA, GVP, and ABPI codes. Being able to discuss these in detail will show your expertise and commitment to compliance.
✨Showcase Your Communication Skills
As a Regulatory Affairs Specialist, you'll need excellent written and verbal communication skills. Prepare examples of how you've effectively communicated complex information in previous roles, especially in relation to compliance and training.
✨Demonstrate Your Attention to Detail
Highlight your ability to review promotional materials and ensure they meet compliance standards. Bring examples of past work where your attention to detail made a significant impact on regulatory submissions or product information.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in a fast-paced environment. Think about past experiences where you had to adapt quickly and prioritise tasks, and be ready to share those stories.
