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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 Contribute to regulatory risk assessments and mitigation strategies Provide expert advice on drug substance control strategies, specifications, characterisation and stability packages Support programme teams through critical development and submission milestones Candidate Profile Essential Experience Approximately 10 years or more of Regulatory CMC experience Strong background in drug substance development Proven experience leading CMC drug substance aspects of global regulatory submissions Deep understanding of Module 3 Quality documentation Excellent working knowledge of ICH, FDA and EMA regulatory requirements Experience supporting late-stage development or registration programmes Highly Desirable Antibody Drug Conjugate (ADC) experience Linker-payload development experience Highly potent API (HPAPI) experience Bioconjugate or complex biologics experience Experience supporting Marketing Authorisation Applications (MAA), BLAs or equivalent global filings EU Rate - €500-€600 p/day Regulatory, CMC, ADC, drug, substance, submission, antibody, conjugate, BLA, MAA, marketing, authorisation, FDA, EMA, module