Director of Regulatory Affairs

Job Summary

Experienced regulatory leaders will find a remote, full-time opportunity as the Director of Regulatory Affairs, responsible for shaping and executing the global clinical regulatory strategy, overseeing clinical submissions, and ensuring compliance with regulatory requirements.

Key Responsibilities

• Define and lead the global clinical regulatory strategy, aligning programs and development milestones
• Oversee the planning and delivery of major clinical regulatory submissions, ensuring quality and compliance
• Direct the development and lifecycle management of global core clinical dossiers and provide guidance on country-specific customization

Required Qualifications

• Bachelor's degree in life sciences or related field; advanced degree strongly preferred
• 12+ years of regulatory affairs experience in biotech/pharma, with substantial leadership experience
• Demonstrated success in leading global IND/CTA submissions and regulatory interactions
• Expertise in ICH GCP and global clinical trial regulations
• Proven experience influencing cross-functional leaders on regulatory strategy