Regulatory Affairs (Pharma) Expert

Regulatory Affairs (Pharma) Expert job at Fresenius Medical Care, leading global regulatory strategy and submissions across various regions, and coordinating electronic submissions with Regulatory Operations. Reporting to the Systems, Quality & Regulatory (SQR) team, this role involves managing post-approval commitments, renewals, and lifecycle activities, while maintaining relationships with health authorities and industry peers.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology, or related field required
• RAC certification or equivalent highly desirable
• 8–10 years of global regulatory affairs experience in drug development and lifecycle management
• Strong hands-on experience with global eCTD submissions
• 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 and electronic gateways

Benefits

• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking
• 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