Regulatory Affairs Strategy Expert

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: 

• Lead global regulatory strategy and submissions across U.S., EU, Canada, LATAM, and APAC 

• Plan, author, and review eCTD submissions (IND, NDA, ANDA, MAA, variations, renewals, supplements) 

• Represent Regulatory Affairs on cross-functional teams, providing guidance on regional requirements and development pathways 

• Provide strategic input on CMC, clinical, and nonclinical documentation for global compliance 

• Coordinate electronic submissions with Regulatory Operations using Veeva Vault RIM, RIMSmart, and global gateways (FDA ESG, CESP, BfArM, Health Canada, ANVISA) 

• Monitor global regulations and communicate key changes to stakeholders 

• Prepare regulatory correspondence, briefing packages, and materials for health authority meetings 

• Manage post-approval commitments, renewals, and lifecycle activities 

• Review labeling, advertising, and promotional materials for regulatory compliance 

• Maintain relationships with health authorities and industry peers 

• Partner with Quality, Clinical, Nonclinical, and Manufacturing to align regulatory documentation 

• Improve regulatory processes and support audits, inspections, and other regulatory projects 

Your Profile: 

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology, or related field required; advanced degree (M.S., Ph.D., Pharm.D.) preferred 

• RAC certification or equivalent highly desirable; ongoing professional development in global regulatory strategy is a plus 

• 8–10 years of global regulatory affairs experience in drug development and lifecycle management across U.S., EU, Canada, LATAM, and APAC 

• Strong hands-on experience with global eCTD submissions (IND, NDA, ANDA, MAA, variations, renewals, supplements) 

• Proven success in global registration strategy and interactions with FDA, EMA, Health Canada, ANVISA, NMPA, and other authorities 

• Deep knowledge of ICH guidelines, regional regulations, and global submission standards 

• Proficiency with regulatory information/publishing systems (e.g., Veeva Vault RIM, RIMSmart) and electronic gateways 

• Broad understanding of CMC, clinical, and nonclinical regulatory requirements 

• Strong project management, communication, and collaboration skills, with the ability to work independently in a global matrix, handle multiple complex projects, and adapt to evolving regulatory requirements 

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.