Leader Regulatory Affairs CMC (drug substance)

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.

• 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)

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.