Regulatory CMC Project Manager

RBW Consulting LLP; United Kingdom; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A regulatory consulting firm is seeking an experienced Senior Regulatory CMC Project Lead to oversee global CMC strategy for small molecule assets. This hybrid role offers a 6-month contract with a strong likelihood of extension. The ideal candidate has over 15 years of experience in CMC regulatory leadership, demonstrates a strategic mindset, and is comfortable managing agency interactions. Apply to make a significant impact in a high-profile position.

Qualifications

• 15+ years’ experience in CMC regulatory leadership.
• Proven track record in small molecule drug development.
• Comfortable leading global regulatory strategy and agency interactions.

Responsibilities

• Leading and executing global CMC regulatory strategies across all development stages.
• Ensuring timely, high-quality delivery of regulatory documents.
• Leading agency interactions and briefing book preparation.

Skills

CMC regulatory leadership

Small molecule drug development

Strategic mindset

Job description

Overview

Contract Opportunity – Senior Regulatory CMC Project Lead (Small Molecules)

Location: Hybrid (EU time zone) - can be remote but travel required

Start: ASAP

We’re hiring a Regulatory CMC Project Lead to take ownership of global CMC strategy for two small molecule assets in development. This is a 6-month contract with a strong likelihood of extension, offering the chance to make a real impact in a high-profile role.

You’ll be working cross-functionally with global teams, driving regulatory strategy across early and late phase development.

Key responsibilities

• Leading and executing global CMC regulatory strategies across all development stages
• Enabling accelerated development pathways through smart regulatory planning
• Ensuring timely, high-quality delivery of regulatory documents (e.g., IMPD/IND)
• Leading agency interactions and briefing book preparation
• Representing CMC Regulatory in cross-functional and governance forums

Additional focus for late-phase asset

• Support technical writing teams with country-specific requirements
• Align dossier strategies with local affiliates and timelines
• Conduct gap analyses and manage submission risks
• Compile and deliver compliant regulatory documents for core markets

What’s needed

• 15+ years’ experience in CMC regulatory leadership
• Proven track record in small molecule drug development
• Strong strategic mindset across early & late phase submissions
• Comfortable leading global regulatory strategy and agency interactions

Please contact Mark Bux-Ryan for more information.

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