Global Regulatory Strategy Director

NCBioImpact; Raleigh (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Merz Therapeutics is seeking aDirector of Regulatory Affairs to lead a team of regulatory professionals. You will guide development and lifecycle strategies, ensuring compliance with US FDA regulations and guidance, while supporting Marketing and Legal on regulatory issues with potential business impact.

The role requires strong leadership, extensive experience with regulatory submissions, and the ability to mentor staff. Join a company dedicated to patient care and regulatory excellence.

Qualifications

• Minimum 10 years regulatory experience.
• Strong knowledge of US drug and biologic regulatory environment and FDA guidance.

Responsibilities

• Lead regulatory strategies for development and lifecycle management of products.
• Oversee and coordinate regulatory submissions to US authorities (INDs, BLAs, NDAs).
• Mentor and supervise regulatory staff; manage budget and resources.
• Serve as primary liaison with global health authorities and FDA audits.
• Collaborate with Marketing and Legal on regulatory issues with business impact.

Skills

Regulatory leadership

Team mentoring

Cross-functional collaboration

FDA/regulatory knowledge

Education

Bachelor's degree in scientific/health discipline

Master's degree preferred

Tools

INDs/BLAs/NDAs submissions

Job description

Merz Therapeutics is seeking aDirector of Regulatory Affairs to lead a team of regulatory professionals. You will guide development and lifecycle strategies, ensuring compliance with US FDA regulations and guidance, while supporting Marketing and Legal on regulatory issues with potential business impact.

The role requires strong leadership, extensive experience with regulatory submissions, and the ability to mentor staff. Join a company dedicated to patient care and regulatory excellence.