Regulatory Affairs Assistant 391

About the job

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

About us

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

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