Senior CMC Reg Consultant, Small Molecules Lifecycle

Excelya

Senior CMC Regulatory Consultant managing lifecycle of small molecule products at Excelya. Working closely with cross-functional teams to ensure robust regulatory strategies and compliance.

Posted 4/24/2026full-timeSaclay • 🇫🇷 FranceSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
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.

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Hard Skills & Tools

CMC regulatory strategyChange Control managementregulatory documentationgap analysisrisk assessmentproject managementlifecycle managementregulatory compliancedocument lifecycle managementsmall molecule asset management

Soft Skills

communicationanalytical skillsorganizational skillscollaborationleadershipstakeholder managementproactive guidancetimely updatescross-functional teamworkproblem-solving