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Cmc Project Manager Orléans – France

0-2 years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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