Director, Global Regulatory Lead

A leading global biopharmaceutical organization is seeking a Director, Global Regulatory Lead to provide strategic regulatory leadership across innovative programs within a growing therapeutic portfolio. This individual will drive global regulatory strategy, lead health authority interactions, and partner cross-functionally to advance products through development, approval, and lifecycle management.

Key Responsibilities:

• Develop and execute global regulatory strategies for complex development programs
• Lead regulatory activities across the product lifecycle, including early development, registration, and post-approval stages
• Serve as the regulatory representative on cross-functional program teams and provide strategic guidance to senior stakeholders
• Lead health authority interactions, including preparation and management of FDA meetings
• Oversee the planning, preparation, and submission of global regulatory applications and supporting documentation
• Identify regulatory risks and opportunities, developing mitigation strategies to support program objectives
• Collaborate with regional regulatory teams to ensure successful global implementation of regulatory strategies
• Contribute to business development activities, due diligence efforts, and cross-functional initiatives
• Mentor and develop regulatory professionals while fostering a collaborative team environment

Qualifications:

• Bachelor's degree in a scientific discipline required; advanced degree preferred
• 8+ years of pharmaceutical or biotechnology industry experience, including significant regulatory affairs experience
• Strong understanding of global drug development and regulatory requirements
• Experience developing and executing regulatory strategies for innovative therapies
• Proven track record leading major regulatory submissions and health authority interactions
• Ability to interpret complex scientific and clinical data and translate insights into regulatory strategy
• Excellent communication, leadership, and stakeholder management skills
• Experience working across global, matrixed organizations