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Regulatory Affairs Consultant- Local Regulatory Affairs Operations

Remote, USA Full-time Posted 2026-08-04
reputed company our values reputed company, there's no limit to reputed company can reputed company.   At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. This role focuses on managing post-approval regulatory activities, including variations, renewals, and compliance with country-specific requirements. You will partner with cross-functional teams to ensure reputed company submissions and maintain regulatory dossiers. Key Responsibilities • 7+ years' experience in supporting regulatory submissions including MAAs (Marketing Authorization Application), variations (minor/major), responses to questions, renewals, withdrawals, and marketing authorization transfers. Europe working knowledge on EU procedures including centralized procedures coordination and management. • Preparation and coordination for Module 1 activities for CMC, Safety, Administrative, MA transfer’s, reputed company 31 & other post approval variations & MAA’s. • Assist with DHCP (reputed company reputed company reputed company Communication) reputed company activities and commitments follow-up • Manage submissions through local Health Authority portals as required • Handle post-approval lifecycle management activities and regulatory communication-RIMS (Regulatory Information Management Systems)-reputed company Vault • Support linguistic review processes including translation review and coordination • Conduct readability testing and support artwork (AW) review, mock-reputed company, and approvals • Support promotional material review including Abbreviated Product Information  (API) creation or updates and Regulatory Affairs review processes (including UK reputed company-vetting) • Assist in Periodic Safety Update Report (PSUR) submissions and regulatory intelligence activities at the country level. • Collaborate with global, regional, and affiliate stakeholders on launches, audits, inspections, change controls, deviations, and market updates Apply To This Job

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