Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Inn

• Provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies
• Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations
• Development and implementation of innovative regulatory strategies and platform approaches
• Provides high quality, timely and clear regulatory advice to allow project teams to make well-informed decisions

• B.S. degree in a science, engineering, or a STEM related field (advanced degree preferred)
• 10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules

Demonstrates extensive expertise in Regulatory CMC leadership, with a focus on developing and implementing innovative regulatory strategies for clinical trials and product registrations. Possesses a strong understanding of global CMC regulatory requirements and the ability to provide clear regulatory advice to project teams.

• Regulatory CMC Leadership
• Global CMC Regulatory Requirements
• Clinical Trials Support
• Innovative Regulatory Strategies
• Synthetic Molecules Commercialization

• Regulatory CMC Experience
• Clinical Development
• Product Registration
• Regulatory Strategy Development
• Technical CMC Knowledge

• Clear Communication
• Decision-Making Support

• Therapeutic Modalities
• Manufacturing Technologies
• Clinical Phases
• STEM Degree