# Senior Regulatory CMC Project lead

**Company:** [Excelya](null/companies/hFGDKUsRdTmwSHu3NyNoMw.md)
**Location:** Remote
**Workplace:** remote
**Employment type:** Full-time
**Department:** Regulatory Affairs

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## Description

**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 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’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.