Senior Regulatory CMC Consultant – ADC Linker-Payload Drug Substance 6-Month Contract (Renewable) Remote – Europe Opportunity An exciting opportunity has arisen for an experienced Senior Regulatory CMC Consultant to support a late-stage oncology programme focused on Antibody Drug Conjugates (ADCs). This is a high-impact consultancy position where you will lead the global regulatory strategy for the linker-payload drug substance component of an innovative ADC programme as it progresses towards major regulatory submissions. Working within a collaborative Regulatory CMC environment, you will play a critical role in ensuring that the drug substance regulatory package is submission-ready for both European and US health authorities. This is a fully remote position within Europe offered initially as a 6-month contract with strong likelihood of extension. Key Responsibilities * Lead Regulatory CMC strategy for the ADC linker-payload drug substance * Provide strategic guidance for global regulatory submissions, including FDA and EMA marketing applications * Drive development and review of Module 3 drug substance documentation * Ensure compliance with current ICH, FDA and EMA regulatory expectations * Support health authority interactions and responses to regulatory questions * Collaborate extensively with CMC, Analytical Development, Process Development, Quality and Manufacturing teams * Contri...
Senior Regulatory CMC Consultant - ADC / Drug Substance • London, London, UK
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