Senior Regulatory CMC Consultant

Senior Regulatory CMC Consultant – ADCs / Drug Substance6-Month Contract (Renewable) Remote – Europe

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
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• 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

• 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

• Highly potent API (HPAPI) experience
• Bioconjugate or complex biologics experience
• Experience supporting Marketing Authorisation Applications (MAA), BLAs or equivalent global filings

Regulatory, CMC, ADC, drug, substance, submission, antibody, conjugate, BLA, MAA, marketing, authorisation, FDA, EMA, module