Regulatory Affairs jobs in United States

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.

• 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, provide additional support:
• 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

• 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.