Regulatory Intelligence and Operational Excellence Lead

Fresenius Medical Care:

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 125,000 employees.

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

SQR:

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!

Your role:

• Own the regulatory intelligence and knowledge-sharing framework for Global Drug Regulatory Affairs (GDRA), linking global, regional and Local RA teams
• Monitor health authority guidance, ICH guidelines, inspection trends and competitor approvals (FDA, EMA, PMDA, Health Canada and others) relevant to CC Products, PD Solutions and Renal Pharma
• Prepare intelligence briefs and reports that turn external and internal information into clear, actionable insights for GDRA leadership and stakeholders
• Capture internal learnings from health authority interactions, approvals, labeling and inspections in a searchable knowledge base
• Enable two-way intelligence exchange with Local RA and regional teams; define when learnings warrant broader communication
• Own the intelligence process (intake, assessment, dissemination, feedback) with standard templates and reporting cadences
• Coordinate GDRA SOP harmonization and lifecycle with process owners: review schedules, version control, change communication, training
• Map and improve cross-functional regulatory workflows; use inspection observations and feedback to support root-cause assessment
• Design, coordinate and improve GDRA onboarding programs, checklists and completion tracking
• Coordinate LDRA process activities and develop training with local and global regulatory colleagues
• Administer POA review cycles and action tracking; escalate overdue items
• Maintain dashboards for SOPs, onboarding, LDRA training, POA actions and improvements; report progress and risks to the Head of Renal Pharma, Operational Excellence and Regulatory Intelligence
• Partner with RA Operations to integrate intelligence into RIMS and GDRA platforms; support due diligence and manage external sources (e.g., Citeline, RAPS)

Your Profile:

• Bachelor’s degree or higher in Pharmacy, Life Sciences, Chemistry, Biochemistry, or a related scientific discipline
• 12–18 years of experience in regulatory affairs, regulatory intelligence, or a closely related function in the pharmaceutical or biotechnology industry
• Demonstrated experience monitoring and synthesizing global regulatory agency guidance (FDA, EMA, ICH and others), with strong scientific literacy to interpret complex regulatory documents and dossier requirements
• Experience with SOP governance, onboarding or training coordination, POA tracking, or continuous improvement; experience in a GBS or shared services environment is a plus
• Proficiency in building and maintaining SharePoint, Teams, RIMS, or similar regulatory knowledge-management platforms
• Excellent written and verbal communication skills, with confidence presenting to senior regulatory leaders and distilling complex information for varied audiences
• Experience working in a global matrix across time zones; builds trust across functions and geographies without direct authority
• Analytical rigor and strategic thinking, with ownership and self-direction to set structure and cadence in a newly created role
• Exposure to NDA, MAA or equivalent submissions; background in CMC, labeling or nonclinical is a plus
• High proficiency in English (written and spoken), the primary working language of GDRA

• Our offer: There is a lot you can discover at Fresenius Medical Care. No matter which field you are an expert in 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 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 Modern office location with hybrid work set up. We are located in Hebbal, Bangalore. You will be entitled to healthcare, insurance and transportation benefits for all employees.

About Us

Creating a future worth living. For patients. Worldwide. Every day.

Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables.

We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.