Global Regulatory Strategy Director

Job Summary

Leading the development and execution of innovative regulatory strategies, the full-time Global Regulatory Strategy Director will manage regulatory submissions and interactions with health authorities while working remotely.

Key responsibilities

• Provide regulatory leadership for assets through Phase 2 and beyond, developing global registrational strategies
• Lead the development of regulatory submissions and identify gaps while creating risk mitigation strategies
• Represent the company with global health authorities and ensure compliance with health authority requirements

Required qualifications

• Bachelor's degree in a scientific discipline; advanced degree (MS, PharmD, or PhD) preferred
• At least 12 years of Regulatory Affairs experience in pharma or biotech, with experience across all development phases
• Strong negotiation skills with health authorities and submission experience from IND/CTx through NDA
• Experience developing regulatory strategies for oral small-molecule programs, particularly in obesity or dermatology
• Demonstrated organizational awareness and experience representing Regulatory Affairs on global teams