Director of Regulatory Affairs

Job Summary

A company is looking for a Director of Regulatory Affairs.

Key Responsibilities

• Develop and lead global regulatory strategies for product development and commercialization
• Oversee the preparation and submission of regulatory documents and ensure alignment with business goals
• Serve as the regulatory point of contact for health authority interactions and lead regulatory meetings

Qualifications

• Advanced degree in life sciences (PhD, PharmD, MS preferred); Bachelor's degree with extensive experience may be considered
• 10+ years of regulatory affairs experience with leadership in global regulatory strategy
• Experience in rare disease and/or respiratory therapeutic areas is highly desirable
• Expertise in U.S. FDA regulations and international regulatory requirements
• Proven track record with INDs, CTAs, and health authority meetings; NDA/MAA experience preferred