CMC Regulatory Assistant – France

Excelya>All job opportunites>Full-time, Permanent Contract>CMC Regulatory Assistant – France

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

Reporting to the Regulatory CMC division, you will work closely with the assistant already in place on the following activities:
– Administrative and operational support for CMC regulatory project managers: Management of quality documentation in the dedicated database, with creation, re-formatting and insertion of technical/CMC documents,
– Requests for legalization, notarization or apostille of documents and sample orders,
– Document updating: input into internal databases.
– Ensure the archiving of original documents and other documents relating to files.
– Contribute to updating data in internal regulatory databases.
– Ensure the department’s document management (eg technical).
– Provide standard assistance to the regulatory CMC Division: correspondence, document formatting, filing, document dispatch, translation requests, travel, expense accounts, meeting organization, signature follow-up, reminders and archiving, welcoming new arrivals and managing requests for access to various tools, managing the Division Manager’s calendar.

Minimum Requirements :

– Trained as an assistant with experience in a pharmaceutical laboratory and at least 2 years’ experience as an assistant in a technical department.
– Qualities required for this position:
o Autonomy, rigor and organization, respect for procedures and deadlines
o Take ownership of their tasks with a solution-oriented approach
o Proficiency in Pack Office (Word, Excel)
o Fluency in written and spoken English
o Good computer skills, use of systems and databases



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