Senior Regulatory CMC Consultant - Biologics

RBW Consulting; United Kingdom; On-site; GBP 148,000 - 221,000; Part time

Job summary

RBW Consulting is seeking an experienced Senior Regulatory CMC Consultant for biologics/ADC programmes. You will lead global regulatory CMC strategy and oversee Module 3 activities for late-stage MAA/BLA submissions, working in an international matrix with Regulatory Affairs, CMC Development, QA and Manufacturing teams.

The role requires strategic leadership with hands-on execution, ensuring alignment of regulatory strategy with programme objectives and facilitating health authority interactions

Qualifications

• Extensive Regulatory CMC experience in biotech/pharma.
• Hands-on leadership of Module 3 for biologics MAA/BLA.
• Deep knowledge of FDA/EMA/ICH and global CMC requirements.
• Experience coordinating cross-functional teams across regulatory, CMC, quality and manufacturing.

Responsibilities

• Develop and implement global Regulatory CMC strategies for late-stage biologics.
• Lead CMC aspects of MAA/BLA submissions, with focus on quality and timely delivery.
• Prepare for and support interactions with health authorities (FDA/EMA) and responses to questions.
• Coordinate regulatory planning and governance across a complex global matrix.

Skills

Regulatory CMC leadership

Module 3 leadership

Biologics expertise

FDA/EMA knowledge

Stakeholder management

Global submission strategy

Job description

Senior Regulatory CMC Consultant - Biologics / ADC Programmes

Global MAA & BLA Strategy | Regulatory CMC Leadership | Contract

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.

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.

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