agap2 Santé is the agap2 department that specialises in the health sector and is involved over the entire life cycle of a health product: drugs, medical systems and biotechnologies. We have activities on Operational and Industrial sites and, for our company development, we are looking for regulatory affairs consultants to assist our customers with their projects.

job description

As a consultant, you will be handling regulatory affairs in the pharmaceutical / medical systems field. In particular, you will be conducting one or more of the following activities:

  • Preparation of specific regulatory requests (request for clinical tests approval, temporary utilisation authorisation (ATU), import requests, etc.),
  • Filing, changes and renewal of MAAs, Drafting,
  • validation and distribution of texts relating to packaging items and to product information,
  • Drafting of procedures related to regulatory activity,
  • Control of promotional elements,
  • Drafting of CE marking documentation.

Profile

A trained pharmacist or scientist, you have an initial experience in the pharmaceutical or medical industry, and particularly in regulatory affairs. For agap2, every talent counts. If you are disabled, please don’t hesitate to ask any questions and to apply.