Senior Regulatory Affairs Professional

Job Summary

Leading complex lifecycle regulatory projects, the full-time Senior Regulatory Affairs Professional will manage lifecycle management activities, oversee regulatory submissions, and ensure compliance with FDA requirements while collaborating with cross-functional teams in a hybrid work environment.

Key responsibilities

• Manage lifecycle management activities, including preparation and submission of regulatory dossiers and applications
• Provide strategic regulatory leadership for post-approval changes and compliance risk management
• Act as a subject matter expert, mentoring team members and driving continuous improvement within the Lifecycle Management team

Required qualifications

• 5-8+ years of experience in Regulatory Affairs with a proven track record in leading complex regulatory projects
• Relevant scientific or technical degree preferred
• Experience in strategic lifecycle thinking and governance
• Demonstrated capability in managing cross-functional teams and influencing stakeholders
• Proven experience with health authority interactions, particularly with the FDA