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Regulatory CMC Project Manager
Job Posted: 23 minutes ago
Salary: £ Competitive
Job Type: Permanent
Location: Buckingham, Buckinghamshire
Expire in: a month
Job Description
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 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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