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:

Responsibilities: 

  • Administrative and operational support for project managers
    CMC regulations: Management of quality documentation in the dedicated
    database, with creation, reformatting and insertion of technical
    of technical CMC documents,
  • Requests for legalisation, notarisation or apostille of documents
    and sample orders,
  • Updating documents: input into internal databases
  • Ensuring the archiving of original documents and other documents
    relating to files.
  • Contribute to the updating of data in the regulatory internal
    databases.
  • Ensure the department’s document management (eg technical)
  • Providing standard assistance to the Regulatory CMC Division: correspondence, formatting documents, filing, sending documents translation requests, travel, expense accounts, organising meetings, monitoring signatures, reminders and archiving, welcoming new arrivals and managing requests for access to the various tools management of the Division Director’s calendar.

Minimum Requirements :

Education and Required Skills

  • Trained as an assistant with experience in a pharmaceutical laboratory laboratory and at least 2 years’ experience as an assistant in a in a technical department.o Autonomy, thoroughness, organisation and respect for procedures
    and deadlines
  • Take ownership of their tasks with a solution-orientedsolutions
  • Proficiency in the Office package (Word, Excel)
  • Professional English, both written and spoken
  • Good computer knowledge, use of systems and databases

Summary

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