Senior Regulatory CMC Project lead

Excelya; France; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Excelya in France is seeking a Senior CMC Regulatory Consultant specializing in small molecule lifecycle management to join our global team. You will provide regulatory input across development to post-marketing, leading the CMC strategy and delivering robust dossiers.

The role requires strong knowledge of EMA, FDA, and ICH frameworks, and the ability to lead multidisciplinary projects while maintaining effective communication. English fluency is essential; French is a plus.

Qualifications

• Extensive experience in CMC regulatory affairs for small molecule lifecycle management.
• Strong knowledge of EMA, FDA, ICH regulatory frameworks.
• 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.

Responsabilités

• Lead the global CMC Regulatory strategy for one small molecule asset (late phase; MAA under preparation).
• Define, develop, own and execute the global CMC Regulatory strategy while maximizing regulatory outcomes.
• Ensure CMC strategies enable accelerated product development pathways.
• Manage project timelines and ensure timely regulatory documents delivery.
• Lead CMC strategy for agency interactions including BB preparation.
• Represent CMC Regulatory in cross-functional meetings as needed.
• Provide CMC Regulatory support to the regulatory CMC writing team.
• Liaise with Local Affiliates to align strategies with country requirements.
• Generate gap analyses and risk management for submissions in core markets.
• Compile regulatory documents for submissions on time and meeting country requirements.

Connaissances

CMC regulatory affairs

Small molecule lifecycle

Global regulatory frameworks

Project leadership

Communication skills

Analytical mindset

Organizational skills

English fluency

French desirable

Formation

Degree in pharmaceutical sciences

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-marking 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 tomanage 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

• 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.

Why Join Us?

At Excelya, we combine passion for science with 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’sleading mid-size CROwith thebest employee experience. Ourone-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 caremeans 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.