Regulatory Affairs Director

Job Summary

As a full-time remote Regulatory Affairs Director, the successful candidate will drive the execution of global regulatory strategies, oversee multiple regulatory programs, and lead a team of Regulatory Affairs professionals while collaborating with cross-functional teams.

Key responsibilities

• Translate company and regulatory strategy into clear regulatory plans across programs and regions
• Oversee the delivery of multiple regulatory programs, managing timelines, quality standards, and client expectations
• Lead and develop Regulatory Affairs Managers and senior team members, setting clear expectations for performance and delivery

Required qualifications

• Advanced degree in life sciences, pharmacy, or a related field
• Significant experience in Regulatory Affairs within pharma, biotech, or CRO environments
• Proven experience managing multiple programs and complex regulatory portfolios
• Strong knowledge of global regulatory frameworks, including Expanded Access Programs and clinical trials
• Demonstrated leadership experience managing teams and developing talent