Regulatory Affairs Director: Global Strategy & Leadership

Merz Therapeutics; Raleigh (NC); On-site; USD 180,000 - 230,000; Full time

Job summary

Merz Therapeutics seeks a Director, Regulatory Affairs to lead development and lifecycle regulatory activities for our products. You will mentor staff and steer global regulatory strategies with R&D, Marketing and Legal.

The role emphasizes delivering compliant, high‑quality submissions, risk assessment, and close collaboration with health authorities to support commercialization and lifecycle management.

Qualifications

• Minimum 10 years relevant regulatory experience.
• Direct experience with INDs, BLAs, and NDAs.
• Strong knowledge of US drug and biologic regulatory environment and FDA guidance.
• Experience with EU/International regulatory preferred.
• Previous experience managing people.

Responsibilities

• Act as both an individual contributor and a coach for team members on regulatory activities.
• Develop and execute global regulatory strategies for development and lifecycle projects.
• Ensure high quality regulatory submissions and planning, with strategic oversight.
• Maintain national registrations, licenses, listings and certifications for compliance.
• Review labeling for regulatory compliance and collaborate with cross-functional teams.
• Liaise with regulators and interact with contract manufacturers and affiliates.
• Provide regulatory intelligence and risk assessments to leadership.
• Coordinate FDA audits of safety information and other regulatory processes.
• Mentor staff and manage regulatory resources including budget and FTE.
• Assist in other duties as assigned.

Skills

Regulatory leadership

Regulatory strategy

US FDA regulations

Team management

Regulatory submissions

Education

Bachelor's Degree in scientific or health discipline

Master's degree in scientific or health discipline

Job description

Merz Therapeutics seeks a Director, Regulatory Affairs to lead development and lifecycle regulatory activities for our products. You will mentor staff and steer global regulatory strategies with R&D, Marketing and Legal.

The role emphasizes delivering compliant, high‑quality submissions, risk assessment, and close collaboration with health authorities to support commercialization and lifecycle management.