Regulatory Affairs & Pharmacovigilance Specialist

Fresenius Medical Care; Willebroek; Hybride; EUR 81 000 - 105 000; Plein temps

Résumé du poste

Fresenius Medical Care in the UK is seeking a Regulatory Affairs & Pharmacovigilance Specialist to lead regulatory activities across the full product lifecycle.

The role requires 3–4 years of regulatory and pharmacovigilance experience, strong knowledge of UK GxP, and collaboration with cross‑functional teams to ensure patient safety and compliant labeling.

Qualifications

• Degree in Life Sciences required or related discipline.
• Proven experience in Regulatory Affairs within the pharmaceutical industry.
• Preferred hands‑on experience with regulatory submissions, compliance, pharmacovigilance, and product lifecycle management.
• Desirable experience in GDP and Compliance.
• Strong knowledge of UK regulations (GxP) and ability to review marketing materials for compliance.

Responsabilités

• Act as the main contact for regulatory and pharmacovigilance matters for internal teams.
• Manage regulatory activities across the full product lifecycle from approval to post‑market compliance.
• Oversee pharmaceutical quality systems and GDP related activities.
• Support product registrations, submissions, and timely market launches.
• Provide regulatory guidance to ensure compliance with local and global requirements.
• Collaborate with cross‑functional teams and external partners (regulators, suppliers).
• Maintain and update regulatory documentation and authorisations.

Connaissances

Regulatory Affairs

Pharmacovigilance

GxP Knowledge

Stakeholder Management

English Fluent

Formation

Degree in Life Sciences

Outils

MS Office

Regulatory Submissions

Description du poste

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 (UK). 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 regulatory and pharmacovigilance, and possess strong expertise in handling licensing and adverse event reporting 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 40 hours, working Monday to Friday, 9am - 5pm – UK time.

Your Responsibilities:

• Act as the main contact for matters relating to regulatory and pharmacovigilance for internal teams.
• Manage regulatory activities across the full product lifecycle, from approval to post-market compliance.
• Responsible for management of the pharmaceutical quality systems.
• 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 respond to queries from 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.
• Support the local responsible person with GDP related activities.
• Ensure compliance with internal procedures and regulatory standards.
• Support training, process improvements, and compliance tracking activities.

Your Profile:

• Degree in Life Sciences, or related discipline.
• Proven experience in Regulatory Affairs within the pharmaceutical industry.
• Preferred hands‑on experience with regulatory submissions, compliance, pharmacovigilance, and product lifecycle management.
• Desirable experience in GDP and Compliance.
• Strong knowledge of relevant regulations (UK) and standards (e.g. GxP), requirements and experience in reviewing marketing materials 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