Regulatory Affairs Officer CMC (Barcelona)

Overview

Asphalion is growing and we are looking for a Scientific & Regulatory Affairs officer to join our CMC unit for the pharmaceutical industry. Someone who loves to take on new challenges, to work in an international environment and who wants to grow with us!

Por favor, asegúrese de leer completamente el resumen y los requisitos de esta oportunidad de empleo que se detallan a continuación.

Main responsibilities

• CMC writing of product specific dossiers (Mod. 2/Mod. 3) for new registration applications and variation packages and renewals mainly in EU and US markets.
• Writing and compilation of product-specific CMC documentation (mainly Module 3 and relevant Module 2 sections) to support lifecycle activities.
• RA CMC change control evaluation/management, when necessary.
• Successful client management of regulatory affairs.
• Responsible for meeting deadlines, ensuring first time quality and maintaining customer ...