Country Expert Drugs Pre & Post Market & Supply Chain Quality

Country Expert Drugs Pre & Post Market & Supply Chain Quality

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!

As a Country Expert - Drugs Pre & Post Market & Supply Chain Quality, you will play a critical role in ensuring that our healthcare products are compliant, safe, and continuously available in the market. You will oversee regulatory activities across the full product lifecycle, including market authorizations, pharmacovigilance, and distribution quality, while acting as a key interface between local operations, global teams, and regulatory authorities.

Your Responsibilities:

• Act as the primary regulatory contact for authorities and internal stakeholders
• Manage regulatory activities across the product lifecycle, including market authorizations, submissions, and updates

• Handling adverse events and ensuring overall compliance with internal and GVP requirements

• As the GDP Qualified Person, you will ensure that QMS, Recall, Training, SOP and CAPA processes remain compliant with GDP and distribution-related requirements.

• Monitor regulatory changes and ensure compliance with local legislation and internal SOPs
• Review and ensure regulatory compliance of marketing materials
• Support audits and inspections, including CAPA implementation
• Collaborate cross-functionally to ensure compliance, product quality, and continuity of supply

• Support across multiple countries may be required to meet business needs.

Your Profile:

• University degree in Life Sciences, Pharmacy, Chemistry, Biology, Medicine or a related scientific discipline.

• Proven experience of 5-6+ years within Regulatory Affairs, Pharmaceutical Industry, Pharmacovigilance and/or GDP/QP environments.

• Solid experience in regulatory submissions, compliance, and product lifecycle management
• Strong knowledge of pharmacovigilance (PV) and/or Good Distribution Practices (GDP)
• Good understanding of local and international regulatory frameworks and GxP requirements
• Strong analytical and organizational skills, with the ability to manage multiple priorities and deadlines
• Effective communication and stakeholder management skills in a cross-functional environment
• Fluent English, with the ability to work in an international setting

• Fluency in additional European languages would be considered an advantage.

The professional qualification requirement for a qualified person is the completion of studies in an accredited healthcare master’s degree program in:

• pharmacy pursuant to special legislation
• or an accredited healthcare master’s degree program in general medicine
• or dentistry
• or an accredited master’s degree program in veterinary medicine
• or an accredited master’s degree program in veterinary hygiene and ecology,
• or in the field of chemistry or biology.

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