At a Glance
- Tasks: Lead regulatory activities for life-saving products and ensure compliance with global standards.
- Company: Join Fresenius Medical Care, a leader in kidney care with a mission to improve patient lives.
- Benefits: Enjoy competitive salary, generous holiday, health cash plan, and career development opportunities.
- Other info: Hybrid role with excellent growth potential in a supportive corporate culture.
- Why this job: Make a real impact in healthcare while working with a passionate and innovative team.
- Qualifications: Degree in Life Sciences and 3-4 years of experience in Regulatory Affairs required.
The predicted salary is between 40000 - 50000 £ per year.
Regulatory Affairs & Pharmacovigilance Specialist
At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease.
Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey.
Guided by our vision—“Creating a future worth living.
For patients.
Worldwide.
Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 employees.
Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes.
Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.
Our values guide how we work
- We Care for our patients, each other, and our communities
- We Connect across teams and borders to deliver excellence together
- We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation
Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle.
The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization.
SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations.
Join our passionate team and help shape healthcare worldwide!
We are seeking a Regulatory Affairs & Pharmacovigilance Specialist to lead and manage regulatory activities across the full product lifecycle within the assigned country.
This role ensures all regulatory requirements for medicines are planned, executed, and maintained in full compliance with international, regional, and local regulations.
The successful candidate will have 3–4 years of experience within the pharmacovigilance field and possess strong expertise in pharmacovigilance regulations and processes.
Acting as the country subject matter expert, you will provide guidance on local regulatory and pharmacovigilance requirements, ensuring ongoing compliance and patient safety.
You will support the successful approval, launch, and ongoing availability of products, overseeing activities from development and registration through to post-market surveillance.
The role plays a key part in driving consistency, efficiency, and alignment of regulatory practices at a country level.
As a subject matter expert, you will provide ongoing regulatory guidance, ensuring continuous compliance and supporting business objectives within a highly regulated environment.
This is a full-time Hybrid role of 37.5 hours, working Monday to Friday, 9am - 5pm. Our head office is based in Huthwaite, Nottinghamshire.
Your Responsibilities
- Act as the main contact for regulatory authorities and internal teams.
- Manage regulatory activities across the full product lifecycle, from approval to post-market compliance.
- Support product registrations, submissions, and timely market launches.
- Provide regulatory advice to ensure compliance with local and global requirements.
- Work closely with cross-functional teams and external partners.
- Take responsibility for local pharmacovigilance activities, including safety reporting and audit support.
- Act as the key contact for PV matters with global teams and health authorities.
- Maintain and update marketing authorisations, ensuring all documentation is accurate and compliant.
- Review product labelling, artwork, and promotional materials.
- Monitor regulatory changes and share key updates with stakeholders.
- Ensure compliance with internal procedures and regulatory standards.
- Support training, process improvements, and compliance tracking activities.
Your Profile
- Degree in Life Sciences, or a related discipline.
- Proven experience in Regulatory Affairs within the pharmaceutical industry.
- Hands-on experience with regulatory submissions, compliance, pharmacovigilance, and product lifecycle management.
- Desirable experience in GDP and Compliance.
- Strong knowledge of relevant regulations and standards (e. g.
Gx P,), with familiarity in GDP requirements and experience applying and interpreting the ABPI Code of Practice, ensuring full compliance with local regulatory frameworks.
- Highly organised, with the ability to manage multiple tasks and deadlines.
- Analytical and detail-oriented, with good problem-solving skills.
- Effective communicator with strong stakeholder management and collaboration skills.
- Confident working across cross-functional teams and with external partners (e. g. regulators, suppliers).
- Proactive mindset with a focus on continuous improvement and compliance excellence.
- Comfortable using IT systems and standard business tools (e. g. MS Office, collaboration platforms).
- Fluent in English; additional languages are an advantage.
- Willingness to travel as required.
Our Offer For You
There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
- Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company
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
- Company paid health cash plan
- Annual leave purchase scheme (with 12 months service)
- Long Service Vouchers
- Cycle to Work Scheme
- Employee Assistance Program (EAP)
- Blue Light card – providing thousands of amazing discounts online and on the high street
Regulatory Affairs & Pharmacovigilance Specialist posts will be subject to a Basic DBS Disclosure
Fresenius Medical Care is an equal opportunities employer
Regulatory Affairs & Pharmacovigilance Specialist employer: Fresenius Medical Care
Fresenius Medical Care in Cornholme offers a supportive and collaborative work environment where employees are valued for their contributions to patient care. With a strong focus on professional development, the company provides ongoing training and growth opportunities, ensuring that team members can advance their careers while making a meaningful impact in the lives of patients. The commitment to maintaining high standards of care and hygiene creates a rewarding atmosphere for those passionate about healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs & Pharmacovigilance Specialist
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Fresenius Medical Care. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Fresenius Medical Care.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Fresenius Medical Care. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Fresenius Medical Care is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs & Pharmacovigilance Specialist
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Fresenius Medical Care!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Fresenius Medical Care that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Fresenius Medical Care!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Fresenius Medical Care, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Fresenius Medical Care
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Fresenius Medical Care that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Fresenius Medical Care’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
