Regulatory CMC Project Manager

​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 aRegulatory CMC Project Leadto take ownership of global CMC strategy for two small molecule assets in development. This is a6-month contractwith astrong 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 focus areas include:

• 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

For the late-phase asset, you’ll also:

• 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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