GlobalRegulatoryLeadPartner

## Accountabilities Serve as the global regulatory lead for assigned products, ensuring maintenance of registrations across key markets including the US and EU. Lead regulatory lifecycle management activities, including strategy development, submission planning, timelines, prioritization, and risk assessment. Manage end-to-end regulatory submissions and health authority interactions, including responses to queries, labeling negotiations, and ongoing regulatory correspondence. Coordinate with subject matter experts to develop and execute response strategies for regulatory authority requests and commitments. Support global labeling activities including CCDS, USPI, SmPC, and country-specific label updates and submissions. Provide regulatory input for periodic safety reports, annual reports, renewals, and other post-approval documentation. Conduct regulatory assessments for tender submissions, product variations, and market-specific registration changes or deletions. Ensure timely execution of agency commitments while maintaining compliance with global regulatory standards and guidelines. Perform regulatory intelligence activities, including review of global guidelines, competitor landscape, and emerging regulatory trends. Collaborate closely with cross-functional teams to ensure alignment and successful execution of global regulatory strategies. Requirements: Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry, Regulatory Affairs, or a related discipline. 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, including exposure to major health authorities. Proven experience leading regulatory activities across multiple geographic regions, ideally covering both small molecules and biologics. Strong understanding of global drug development processes, regulatory frameworks, and post-approval lifecycle management. Experience interacting directly with health authorities and leading responses to regulatory questions and subm