Regulatory Affairs Expert (Esplugas de Llobregat)

Regulatory Affairs Expert Position

We are looking for a Regulatory Affairs Expert to join our Regulatory Affairs Team.

Responsibilities

• Compilation, evaluation and submission of complete registration dossiers to specific regulatory agencies, of both internal development and in-licensing products; under other RA team senior associate supervision. Contact with suppliers and clients, as needed, in order to obtain a dossier that meets the requirements of the country of destination.
• Support in developing and writing clear arguments and explanations for deficiency letters.
• Maintenance of approved dossiers and RA internal databases. Monitoring, updating and adapting documents, preparing submissions of variations and renewals to strict deadlines; under other RA team senior associate supervision.
• Compilation and Evaluation of ASMF.
• Writing clear, accessible product labels and patient information leaflets.
• Review of...