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Regulatory CMC Project Manager
Descripción de la vacante
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.
Formación
- 15+ years’ experience in CMC regulatory leadership.
- Proven track record in small molecule drug development.
- Comfortable leading global regulatory strategy and agency interactions.
Responsabilidades
- 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.
Conocimientos
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
- 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.
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