About the job

We are seeking for a Regulatory Affairs Assistant responsible for ensuring administrative support to the regulatory activities :

About us

Group 10
Responsibilities

  • Participation in the preparation, update and draft of the regulatory documents required for the dossier, according to the regulations in force, the relevant guidelines and the client’s directives
  • Collect or arrange the collection of the required documents from internal collaborators and/or external partners and verify its completeness and consistency
  • Collect and arrange administrative documents (Organize signatures, legalization, translation of regulatory documents…)
  • Compile the regulatory documents required for the registration and/or marketing of products
  • Manage the expedition of the documents to local partners within the given deadlines
  • Ensure achiving of documents in electronic databases (E.D.M.S)
  • Regular updates of regulatory databases
  • Participate in regulatory affairs team activities, communication with clients and local contacts
  • Provide ad-hoc support to other activities (e.g. : artworks review, tracker updates…) when needed

 

Group 13
Skills

Our preferred candidate has the following qualifications and experience:

  • A first experience in regulatory affairs or in a Life Science environement represents a plus
  • Ability to work independently and effectively across functions and geographies
  • Team player with good interpersonal skills
  • Ability to learn in a demanding environment
  • Fluency in French and English both written and spoken for business continuity. Spanish would be a plus
  • Openness to travel in Paris region

Regulatory Affairs Assistant 391