• Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. • Play a hands-on role in planning, preparing, and coordinating CMC documents for submission to global health authorities. • Partner and work very closely with internal and external cross-functional team members to ensure achievement of submission deadlines. • Lead and support interactions with FDA and other Health Authorities for CMC-related topics. • Maintain up-to-date knowledge and understanding of global regulatory requirements.