Senior Regulatory Cmc Project Lead

EXCELYA; Saclay; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Excelya is seeking a Senior CMC Regulatory Consultant to lead the CMC regulatory strategy for a late-phase small molecule asset (MAA under preparation) and to manage the CMC Dossier with support from the regulatory CMC writing team.

You will collaborate with cross-functional teams and global affiliates to ensure robust regulatory strategies, submission excellence, and timely regulatory deliverables across core markets.

Qualifications

• Degree in pharmacy, chemistry, pharmaceutical sciences, or related field.
• Extensive experience in CMC regulatory affairs focused on small molecule lifecycle management.
• Strong knowledge of EMA, FDA, ICH frameworks and lifecycle management.
• Proven ability to lead CMC regulatory projects across multidisciplinary teams.

Responsabilités

• Lead the global CMC Regulatory strategy for the asset (late phase; MAA under preparation).
• Define and own global CMC Regulatory strategy and ensure favorable regulatory outcomes.
• Represent CMC Regulatory in cross-functional governance meetings and agency interactions.
• Provide regulatory support to writing teams and liaise with local affiliates to meet country requirements and timelines.
• Generate risk analyses and prepare regulatory documents for core market submissions.

Connaissances

CMC regulatory affairs

Regulatory leadership

Cross-functional collaboration

Excellent communication

English fluent

Formation

Pharmacy degree

Description du poste

About the Job

At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team.

This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.

The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to manage and deliver the CMC Dossier with the support of the technical writing team within the Regulatory CMC.

Main Responsibilities

• Leading the global CMC Regulatory strategy for one small molecule asset (late phase; MAA under preparation)
• Defining, developing, owning and executing the global CMC Regulatory strategy whilst maximizing the regulatory outcomes for this asset.
• Ensure that CMC Regulatory strategies are an enabler to potential accelerated product development pathways to ensure speed up product delivery to patients.
• Effective project management skills to ensure high quality and timely delivery of regulatory documents.
• Leading the CMC strategy for all agency interactions for the allocated asset (including the preparation of the BB).
• Represent CMC Regulatory on the asset cross-functional technical, regulatory and governance meetings as needed.
• Provide CMC Regulatory support to the Reg CMC technical writing team in relation to the respective country requirements
• Liaise with the Local Affiliate of the respective countries to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines
• Generate gap analysis and risk management support for each submission in the core markets as needed
• Compile regulatory documents in support of each submission in the core markets on time and in line with country requirements

Requirements

• 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 (EMA, FDA, ICH) and 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

Why Join Us?

At Excelya, we combine passion for science and enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique-

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model-offering full-service, functional service provider, and consulting- enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.