# Senior CMC Reg Consultant (Small Molecules Lifecycle)

**Company:** [Excelya](http://jobs.workable.com/companies/hFGDKUsRdTmwSHu3NyNoMw.md)
**Location:** Saclay, France
**Workplace:** hybrid
**Department:** Regulatory Affairs

[Apply for this job](http://jobs.workable.com/view/ffcc4851-7eaa-4d94-a7b7-e59b75c19497)

## 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.

**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

**Candidate Profile:**

-   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.
-   Degree in pharmacy, chemistry, pharmaceutical sciences, or related field.
-   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.