RBW Consulting
Senior Regulatory CMC Consultant
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Senior Regulatory CMC Consultant – ADCs / 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.
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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
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- 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
Regulatory, CMC, ADC, drug, substance, submission, antibody, conjugate, BLA, MAA, marketing, authorisation, FDA, EMA, module
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