Global Regulatory Affairs Director

Job Summary

A company is looking for a Director of Global Regulatory Affairs - Neurosciences.

Key Responsibilities

• Lead the development and implementation of global regulatory strategies aligned with product team objectives
• Monitor global regulatory requirements and provide training and intelligence to ensure compliance and risk mitigation
• Serve as a strategic advisor on regulatory matters, representing the company in interactions with health authorities

Required Qualifications, Training, and Education

• Experience in regulatory affairs or related areas in pharmaceutical drug development
• Experience managing regulatory aspects of IND and global clinical trial activities
• Experience in CNS/sleep therapeutic area preferred
• PharmD, Bachelor's, Master's, or advanced degree in a scientific discipline
• Proven track record of collaboration with regulatory agencies, including the FDA