Senior Director, Global Regulatory Strategy & Submissions

Merz; Raleigh (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Merz Therapeutics seeks a Director of Regulatory Affairs to lead a team of regulatory professionals. You will craft and execute regulatory strategies for new products and manage lifecycle activities, ensuring submissions meet timelines and comply with US FDA regulations.

This role requires strong leadership, cross-functional collaboration and budget oversight. Daily responsibilities include global regulatory planning, risk assessment, labeling reviews, and liaison with Health Authorities,

Qualifications

• Bachelor's degree in a scientific or health discipline is required.
• At least 10 years of relevant regulatory experience, with IND/BLA/NDA submissions.
• Strong knowledge of US FDA regulations and guidance; international experience preferred.
• Experience mentoring staff and managing regulatory resources and budgets.

Responsibilities

• Lead development and execution of global regulatory strategies for products.
• Oversee timely regulatory submissions and strategic oversight of documents.
• Maintain national registrations, licenses and labeling in compliance.
• Coordinate with agencies, manufacturers, affiliates and distributors.
• Mentor staff and manage budget/FTE; report regulatory risks to leadership.

Skills

Regulatory leadership

IND/BLAs/NDAs submissions

FDA regulations knowledge

People management

EU/International regulatory

Education

Bachelor's degree in scientific or health discipline

Master's degree in scientific or health discipline (preferred)

Job description

Merz Therapeutics seeks a Director of Regulatory Affairs to lead a team of regulatory professionals. You will craft and execute regulatory strategies for new products and manage lifecycle activities, ensuring submissions meet timelines and comply with US FDA regulations.

This role requires strong leadership, cross-functional collaboration and budget oversight. Daily responsibilities include global regulatory planning, risk assessment, labeling reviews, and liaison with Health Authorities,