• Manage, evaluate, and complete regulatory projects consistent with company goals • Lead, develop and implement small molecule CMC regulatory strategies • Authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global submissions • Develop regulatory strategy and execute in the preparation of timely responses • Work collaboratively with cross-functional leads and communicates CMC regulatory strategies • Lead regulatory risk assessment, identify key CMC regulatory issues • Provide CMC regulatory review for clinical protocols and investigator brochures for the assigned project