Regulatory Affairs Director

Job Summary

A company is looking for a Regulatory Affairs Director to support global clinical development programs in the biotechnology sector.

Key Responsibilities

• Provide senior regulatory leadership and strategic guidance for late-stage clinical development programs
• Lead global regulatory strategy for Phase III clinical programs, focusing on vaccines
• Manage regulatory submissions and interactions with agencies, ensuring NDA/BLA readiness

Required Qualifications

• Extensive Regulatory Affairs experience (typically 12-15+ years) within biotech or pharmaceutical industries
• Proven experience leading global regulatory strategies for Phase III clinical programs
• Vaccine experience is strongly preferred
• Prior experience with NDA/BLA submissions or late-stage regulatory interactions is a plus
• Strong leadership and stakeholder management skills