Senior Regulatory CMC Consultant - Biologics

Senior Regulatory CMC Consultant - Biologics / ADC Programmes Global MAA and BLA Strategy Regulatory CMC Leadership Contract We''re supporting a global pharmaceutical organisation as they strengthen Regulatory CMC leadership across a high-profile biologic Antibody-Drug Conjugate (ADC) programme approaching major regulatory milestones. This opportunity will suit an experienced Regulatory CMC professional who combines strategic leadership with hands-on execution and has a proven track record leading Module 3 activities for biologic MAA and/or BLA submissions. Operating within an international matrix environment, you will partner closely with Regulatory Affairs, CMC Development, Quality, Manufacturing and Technical Writing teams to drive global registration readiness and submission success. The Opportunity Lead the global Regulatory CMC strategy for a late-stage biologic ADC programme intended for worldwide registration. Provide strategic guidance and oversight for global MAA and BLA preparation, submission and review activities. Drive alignment between CMC development activities, regulatory strategy and wider programme objectives. Lead cross-functional regulatory planning, governance and risk management across multiple internal and external stakeholders. Act as a senior Regulatory CMC advisor supporting health authority interactions across major global markets. Key Responsibilities Develop and execute global Regulatory CMC strategies for complex biologic products. Lead ..... full job details .....