Senior Manager, Regulatory Affairs

Job Summary

Supporting continuous improvement and operational excellence efforts, the full-time Senior Manager, Regulatory Affairs will manage process optimization activities and collaborate with cross-functional teams in a remote environment.

Key responsibilities

• Supports planning and execution of continuous improvement and process optimization activities across the Global Regulatory Affairs organization
• Contributes to cross-functional team efforts by coordinating project planning, execution, and monitoring of regulatory operational support
• Assists in defining and tracking key performance indicators (KPIs) to monitor process effectiveness and compliance

Required qualifications

• Bachelor's degree in Life Sciences, Business Administration, or related field (Advanced degree preferred)
• 5+ years of experience in the pharmaceutical and/or biotech industry
• 3+ years of experience in Regulatory Affairs or drug development project management
• Knowledge of Lean, Six Sigma, and continuous improvement methodologies
• Demonstrated experience leading complex, cross-functional continuous improvement initiatives