# RegCMC consultant with drug substance development experience

> Excelya · Saclay, France · Full-time · Posted 2026-07-23

**Workplace:** on_site

**Department:** Regulatory Affairs - Resourcing

## Description

**About the Job**

At Excelya, where **Audacity, Care, and Energy** are at the core of everything we do, we are seeking a **CMC Regulatory Consultant** specializing in drug substance 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 Regulatory CMC Department is looking for a senior consultant with drug substance development experience, he/she will mainly be responsible for leading the regulatory strategy.

Main Responsibilities:

-   Lead the CMC regulatory strategy for all post‑approval lifecycle activities of assigned small‑molecule assets, providing proactive and timely regulatory guidance to technical teams.
-   Manage and deliver all regulatory aspects related to Change Control requests, ensuring compliance with global regulatory requirements.
-   Drive and coordinate project management activities supporting CMC post‑approval work, ensuring deliverables are completed on time, within scope, and at the required quality level.
-   Liaise with local affiliates to define efficient and compliant regulatory strategies aligned with country‑specific requirements and agreed timelines.
-   Represent CMC Regulatory in governance meetings and cross‑functional project forums.
-   Write, review, compile, and submit CMC regulatory documentation in support of global post‑approval submissions, in accordance with regional requirements.
-   Perform gap analyses and risk assessments to support regulatory strategy and readiness for submissions.
-   Identify critical path activities, interdependencies, and rate‑limiting factors across technical and regulatory deliverables.
-   Provide clear and regular status updates to internal and external stakeholders.
-   Ensure effective document lifecycle management through the appropriate document management systems.

## Requirements

-   Previous experience leading the CMC DS aspects of global Marketing Authorization submissions (EU & FDA)
-   Strong regulatory strategic skills and ability to be successful in a multi-faceted environment
-   Knowledgeable in ICH, FDA and EMA guidelines and requirements for the DS part of a Module 3
-   Experience working collaboratively in multi-functional teams, network and alliance building
-   Well organized, scientifically driven, pragmatic and open
-   Excellent critical thinking and problem-solving skills
-   Comfortable with and capable of prioritizing multiple tasks, projects and objectives
-   Fluent in English (written, spoken, and read)

## 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.

## Apply

[Apply at Excelya](https://apply.workable.com/excelya/j/E51E469212/apply)

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