Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Innovati

Deep technical knowledge of biologics CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences). Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations and maintaining approved registrations. Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment (new guidance, evolving expectations, and regulatory precedent). Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning. Leads preparation, critical review, and approval of CMC documents for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and health authority information requests. Takes a proactive leadership role in the critical review of molecule...Regulatory Affairs, Director, Chemistry, Controls, Regulatory, Manufacturing, Technology