Senior Regulatory Affairs Specialist

Leading complex lifecycle regulatory projects, the full-time Senior Regulatory Affairs Specialist will manage lifecycle management activities, ensuring compliance with FDA requirements and overseeing the preparation and submission of regulatory dossiers while working in a hybrid environment. Key responsibilities Manage and lead high-impact lifecycle regulatory projects across multiple drug products and markets Provide strategic oversight for post-approval changes and ensure compliance with regulatory requirements Act as a regulatory lead for health authority interactions and mentor junior colleagues within the team Required qualifications 5-8+ years of experience in Regulatory Affairs with a proven track record in leading complex projects Relevant scientific or technical degree preferred Experience in strategic lifecycle thinking and governance Demonstrated ability to influence cross-functional teams without formal authority Strong capability in coaching and mentoring others in regulatory practices