RBW Consulting
Senior Regulatory CMC Consultant - Biologics
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Senior Regulatory CMC Consultant - Biologics / ADC Programmes
Overview
We're supporting a global pharmaceutical organisation as they strengthen Regulatory CMC leadership across a high-profile biologic Antibody-Drug Conjugate (ADC) programme approaching major regulatory milestones.
The Opportunity
Lead the global Regulatory CMC strategy for a late-stage biologic ADC programme intended for worldwide registration.
- Provide strategic guidance and oversight for global MAA and BLA preparation, submission and review activities.
- Drive alignment between CMC development activities, regulatory strategy and wider programme objectives.
- Lead cross-functional regulatory planning, governance and risk management across multiple internal and external stakeholders.
- Act as a senior Regulatory CMC advisor supporting health authority interactions across major global markets.
Key Responsibilities
- Develop and execute global Regulatory CMC strategies for complex biologic products.
- Lead CMC aspects of MAA and/or BLA submissions, ensuring quality, compliance and timely delivery.
- Review and finalise Module 3 documentation, ensuring scientific robustness and regulatory suitability.
- Lead preparation for FDA, EMA and other global health authority interactions, including briefing documents and regulatory responses.
- Provide strategic input on regulatory positioning, risk mitigation and agency engagement plans.
- Coordinate cross-functional activities across Regulatory Affairs, CMC, Technical Operations, Quality and Manufacturing.
- Support responses to health authority questions, deficiency letters and post-submission activities.
- Ensure compliance with evolving global regulations, guidelines and CMC expectations for biologics and ADC products.
- Drive stakeholder alignment and delivery across a complex global matrix structure.
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Consultant Profile
We are particularly interested in Regulatory CMC professionals who can demonstrate:
- Extensive Regulatory Affairs CMC experience within biotechnology and/or pharmaceutical environments.
- Proven hands-on leadership of Module 3 activities supporting biologic MAA and/or BLA submissions.
- Strong expertise across biologics, including complex products and advanced therapeutics.
- Experience developing and implementing global Regulatory CMC strategies through late-stage development and registration.
- Deep understanding of FDA, EMA, ICH and global CMC regulatory requirements.
- Experience preparing and supporting health authority interactions, scientific advice meetings and regulatory negotiations.
- Strong stakeholder management and matrix leadership capability.
- The ability to operate strategically whilst remaining hands-on when required.
- Excellent communication, collaboration and problem-solving skills.
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Cmc, regulatory, affairs, ADC, antibody, drug, conjugate, biologics, large, molecule, submission, BLA, MAA, consultant, interim, freelance
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