Senior Regulatory CMC Consultant - ADC / Drug Substance

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