Senior Regulatory CMC Consultant

Senior Regulatory CMC Consultant – Small Molecule Drug Substance 6-Month Contract (Renewable) Remote – Europe Must bring a specific focus on small molecule drug substance regulatory CMC activities. OpportunityAn 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 ResponsibilitiesLead Regulatory CMC strategy for the ADC linker-payload drug substanceProvide strategic guidance for global regulatory submissions, including FDA and EMA marketing applicationsDrive development and review of Module 3 drug substance documentationEnsure compliance with current ICH, FDA and EMA regulatory expectationsSupport health authority interactions and responses to regulatory questionsCollaborate extensively with CMC, Analytical Development, Process Development, Quality and Manufacturing teamsContribute to regulatory risk assessments and mitigation strategiesProvide expert advice on drug substance control strategies, specifications, characterisation and stability packagesSupport programme teams through critical development and submission milestones Candidate ProfileEssential ExperienceApproximately 10 years or more of Regulatory CMC experienceStrong background in drug substance developmentProven experience leading CMC drug substance aspects of global regulatory submissionsDeep understanding of Module 3 Quality documentationExcellent working knowledge of ICH, FDA and EMA regulatory requirementsExperience supporting late-stage development or registration programmesHighly DesirableAntibody Drug Conjugate (ADC) experienceLinker-payload development experienceHighly potent API (HPAPI) experienceBioconjugate or complex biologics experienceExperience 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