Regulatory Intelligence and Operational Excellence Lead
BengaluruFull-timeHybrid12–18 yrsPosted 2 weeks ago
Leadership legal role at INSC IND GBS India in Bengaluru. Needs 12–18 years. Hybrid.
About the role
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.
What you'll do
- 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
- 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
What you need
- SOP writing
- Regulatory affairs
- Chemistry
- Due diligence
- Compliance