Director of Regulatory Affairs

Job Summary

A company is looking for a Director of Regulatory Affairs.

Key Responsibilities

• Lead global regulatory strategy for Phase III clinical programs, particularly for vaccines
• Provide hands-on leadership for regulatory submissions and interactions, including NDA/BLA readiness
• Advise internal stakeholders on regulatory requirements and risk mitigation strategies

Required Qualifications

• Extensive Regulatory Affairs experience (typically 12-15+ years) in biotech/pharma
• Proven experience leading global regulatory strategy for Phase III clinical programs
• Vaccine experience strongly preferred
• Prior experience with NDA/BLA submissions or late-stage regulatory interactions is a plus
• Demonstrated ability to operate effectively in fast-paced, high-pressure environments