Global Head of Regulatory Affairs

Job Summary

Providing global oversight and leadership, the full-time Global Head of Regulatory Affairs will manage teams focused on Chemistry, Manufacturing and Control (CMC), Quality, and Medical Device & Diagnostic consulting services, driving strategic direction and business development in a remote or office-based environment.

Key responsibilities:

• Sets the vision and guides the achievement of goals for the Technical regulatory CMC, Quality, and MDD function
• Oversees the development and execution of regulatory strategies, ensuring compliance with global standards
• Identifies and leads regulatory technical initiatives while managing staff development and departmental performance

Required qualifications:

• Expert understanding of scientific principles and regulatory CMC, Quality, and MDD requirements for global drug development
• Expert knowledge of regulatory review and approval processes from relevant Health Authorities and Notified Bodies
• Experience in pharmaceutical drug and device development, including product maintenance and global regulations
• Advanced leadership skills in change management and strategic thinking
• Ability to manage multiple projects effectively and deliver on complex project timelines