Senior Director, Regulatory Affairs (Office or Remote)

The Senior Director of Regulatory Affairs provides regulatory leadership, develops regulatory strategies, and advises the broader regulatory function on US and international market approvals for products. This role involves interpreting regulations, preparing submissions to authorities, and managing internal and external relationships.

Requirements

• Provides strong regulatory and scientific leadership
• Interprets and applies regulations
• Manages development of INDs and global clinical trial applications
• Coordinates meetings with regulatory agencies
• Develops relationships with external partners
• Provides guidance and training to regulatory staff
• Prepares and revises internal procedures
• Manages activities performed by regulatory

Benefits

• Stock programs
• Performance-based bonus
• Comprehensive benefits package