About the job

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

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

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

Publish Date

15 May, 2021

Spontaneous Application

Regulatory Affairs Assistant 391

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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