Senior Regulatory CMC Lead – Biologics & ADC Submissions

RBW Consulting; Greater London; On-site; GBP 90,000 - 130,000; Full time

Job summary

RBW Consulting is seeking a Senior Regulatory CMC Consultant to lead biologics/ADC programme registration strategies globally. The role combines strategic leadership with hands-on execution across MAA and BLA activities.

You will partner with Regulatory Affairs, CMC Development, Quality and Manufacturing in an international matrix, guiding Module 3 documentation, health authority interactions and risk management to ensure timely submissions.

Qualifications

• Extensive Regulatory Affairs CMC experience in biotech/pharma.
• Lead Module 3 activities for biologic MAA and/or BLA submissions.
• Global Regulatory CMC strategy development for late-stage programs.
• Strong knowledge of FDA/EMA/ICH global CMC requirements.

Responsibilities

• Lead global Regulatory CMC strategy for late-stage biologic ADC programme.
• Oversee global MAA and BLA submissions, review and timing.
• Align CMC development with regulatory strategy and program goals.
• Lead cross-functional regulatory planning across multiple stakeholders.
• Coordinate FDA/EMA interactions, briefing documents and responses.
• Support responses to health authority questions and deficiency letters.
• Ensure compliance with evolving global CMC regulations for biologics.

Skills

Regulatory Affairs CMC

Module 3 leadership

Biologics expertise

Global CMC strategy

FDA/EMA knowledge

Health authority interactions

Stakeholder management

Strategic + hands-on

Communication & collaboration

Job description

RBW Consulting is seeking a Senior Regulatory CMC Consultant to lead biologics/ADC programme registration strategies globally. The role combines strategic leadership with hands-on execution across MAA and BLA activities.

You will partner with Regulatory Affairs, CMC Development, Quality and Manufacturing in an international matrix, guiding Module 3 documentation, health authority interactions and risk management to ensure timely submissions.