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

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

• Regulatory CMC Leadership


• Global CMC Regulatory Requirements


• Clinical Trials Support


• Innovative Regulatory Strategies


• Synthetic Molecules Commercialization

ATS Optimization Keywords

Hard Skills

• Regulatory CMC Experience


• Clinical Development


• Product Registration


• Regulatory Strategy Development


• Technical CMC Knowledge

Soft Skills

• Clear Communication


• Decision-Making Support

Industry Keywords

• Therapeutic Modalities


• Manufacturing Technologies


• Clinical Phases


• STEM Degree