Global Director, Regulatory Affairs & Strategy

Merz Pharmaceuticals LLC; Raleigh (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

Merz Therapeutics in the United States seeks a Director of Regulatory Affairs to lead a team of regulatory professionals. You will guide development and lifecycle strategies for new products, oversee submissions, and ensure compliance with US FDA regulations.

Collaboration with Marketing and Legal is essential to manage regulatory impact on business strategy. The role requires extensive experience in regulatory affairs, people management, and a background in INDs/BLAs/NDAs, with preference for

Qualifications

• Minimum 10 years regulatory experience
• Direct experience with development, preparation and submission of INDs, BLAs, and NDAs
• Strong knowledge of US drug and biologic regulatory environment and FDA regulations
• Previous experience managing people
• Experience with EU/International Regulatory preferred

Responsibilities

• Act as mentor and coach for staff on regulatory activities
• Develop and execute global regulatory strategies for development and lifecycle projects
• Coordinate regulatory submissions planning and preparation
• Maintain national registrations, licenses, listings and other certifications
• Review labeling for regulatory compliance and liaison with agencies
• Provide regulatory intelligence and risk assessments to leadership
• Coordinate pharmacovigilance activities and FDA audits as needed
• Manage regulatory resources including budget and FTE
• Perform other duties as assigned

Skills

Regulatory strategy

People management

IND/BLAs/NDAs

FDA regulations

Education

Bachelor's Degree in science/health

Master's degree preferred

Job description

Merz Therapeutics in the United States seeks a Director of Regulatory Affairs to lead a team of regulatory professionals. You will guide development and lifecycle strategies for new products, oversee submissions, and ensure compliance with US FDA regulations.

Collaboration with Marketing and Legal is essential to manage regulatory impact on business strategy. The role requires extensive experience in regulatory affairs, people management, and a background in INDs/BLAs/NDAs, with preference for