CMC Project Manager – Orléans, France
Slug: cmc-project-manager-orleans-france-excelya
Position: CMC Project Manager
Type: Full-time, Permanent
Location: Orléans, France
Company: Excelya
Why Join Excelya:
Excelya is a fast-growing healthcare company with a vibrant team of over 900 professionals ("Excelyates"), driven to become Europe’s top mid-size CRO. With its one-stop service model—covering full-service support, functional service provision, and expert consulting—Excelya offers diverse career opportunities and fosters a culture where science meets care. Collaborating with industry experts, you will help advance healthcare innovation and positively impact patients' lives.
About the Role:
As a CMC (Chemistry, Manufacturing and Controls) Project Manager, you will play a strategic role in overseeing the CMC aspects of one or more drug development programs, including those involving New Chemical Entities (NCEs) or novel drug combinations. You’ll lead cross-functional teams, manage international partnerships, and ensure that CMC deliverables align with regulatory standards, project goals, and clinical timelines.
Key Responsibilities:
Act as the CMC representative within the global development (core) team
Lead the cross-functional CMC sub-team (drug substance, drug product, quality, regulatory, etc.)
Coordinate with external development and manufacturing partners, including international subcontractors
Define, implement, and adjust the CMC development strategy for each assigned project
Develop and manage CMC project plans, timelines, and deliverables
Perform risk assessments and develop mitigation plans with internal CMC team
Ensure compliance with regulatory expectations and project goals
Collaborate with regulatory, clinical, commercial, and quality departments
Oversee project budgets and internal/external resource allocation
Provide CMC documentation for regulatory submissions
Candidate Profile:
Experience: Capable of excelling in fast-paced, collaborative environments
Skills:
Strong understanding of pharmaceutical development stages
Experience in clinical supply management, regulatory documentation, and industrial transfer
Education: Degree in Regulatory Affairs
Languages: Fluency in French and English is required
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