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. Regulatory, CMC, project, lead, manager, technical, writer, reg, RA, asset, development. Registration, phase, late, early, freelance, interim, contract