Senior Regulatory CMC Project Lead

Excelya

. Lead the global CMC Regulatory strategy for one small molecule asset in late phase, with MAA under preparation .

Posted 9/18/2026full-timeRemote • FranceSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading global CMC Regulatory strategies for small molecules, ensuring compliance with EMA, FDA, and ICH standards while effectively managing cross-functional teams and regulatory submissions.

Highest-signal resume keywords

CMC Regulatory Strategy DevelopmentSmall Molecule Lifecycle ManagementGlobal Regulatory Framework KnowledgeProject Management for Regulatory SubmissionsFluency in English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory AffairsRegulatory Document CompilationGap Analysis GenerationRisk Management SupportLifecycle Management Principles

Soft Skills

Excellent Communication SkillsAnalytical SkillsOrganizational SkillsCollaboration with Multidisciplinary Teams

Industry Keywords

Pharmaceutical IndustryRegulatory SubmissionsEMAFDAICH

About the role

Key responsibilities & impact

Lead the global CMC Regulatory strategy for one small molecule asset in late phase, with MAA under preparation
Define, develop, own, and execute the global CMC Regulatory strategy while maximizing regulatory outcomes
Ensure CMC Regulatory strategies enable potential accelerated product development pathways and speed product delivery to patients
Manage projects to ensure high-quality and timely delivery of regulatory documents
Lead the CMC strategy for agency interactions, including preparation of the BB
Represent CMC Regulatory in asset cross-functional technical, regulatory, and governance meetings as needed
Provide CMC Regulatory support to the Regulatory CMC technical writing team regarding country requirements
Liaise with local affiliates to develop efficient regulatory strategies for delivering the CMC Dossier according to country requirements and agreed timelines
Generate gap analyses and provide risk management support for submissions in core markets
Compile regulatory documents for submissions in core markets on time and according to country requirements

Requirements

What you’ll need

Degree in pharmacy, chemistry, pharmaceutical sciences, or related field
Extensive experience in CMC regulatory affairs focused on small molecule lifecycle management, preferably within pharmaceutical industry or consultancy
Strong knowledge of global regulatory frameworks, including EMA, FDA, and ICH
Knowledge of lifecycle management principles
Proven ability to lead CMC regulatory projects and collaborate with multidisciplinary teams
Excellent communication, analytical, and organizational skills
Fluency in English
French language skills are a plus

Benefits

Comp & perks

Opportunity to work at Excelya, a health company and mid-size CRO
Diverse projects through a one-stop provider service model offering full-service, functional service provider, and consulting
Work alongside preeminent experts
Environment that values natural talents, pushes boundaries, and nurtures professional potential
Opportunity to contribute to improving scientific, operational, and human knowledge and enhancing the patient’s journey