Leader Regulatory Affairs Cmc Drug Substance H/F Excelya
- Saclay - 91
- CDI
- Bac +5
- Industrie Pharmaceutique • Biotechn. • Chimie
Les missions du poste
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 postapproval lifecycle activities of assigned smallmolecule 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 postapproval 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 countryspecific requirements and agreed timelines.
- Represent CMC Regulatory in governance meetings and crossfunctional project forums.
- Write, review, compile, and submit CMC regulatory documentation in support of global postapproval 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 ratelimiting 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.
Le profil recherché
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'sleading mid-size CROwith thebest employee experience. Ourone-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 caremeans 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.
- 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)
Bienvenue chez Excelya
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.
Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.
We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
Publiée le 27/07/2026 - Réf : 827942cc-b41b-4d39-bd89-3fb7dc5dfe20
