Senior CMC Reg Consultant (Small Molecules Lifecycle)

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.