Senior Regulatory CMC Consultant - Biologics

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.

This opportunity will suit an experienced Regulatory CMC professional who combines strategic leadership with hands-on execution and has a proven track record leading Module 3 activities for biologic MAA and/or BLA submissions. Operating within an international matrix environment, you will partner closely with Regulatory Affairs, CMC Development, Quality, Manufacturing and Technical Writing teams to drive global registration readiness and submission success.

• 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.

• 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.

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.

Cmc, regulatory, affairs, ADC, antibody, drug, conjugate, biologics, large, molecule, submission, BLA, MAA, consultant, interim, freelance