Regulatory Affairs Manager (Santiago)

Company Description

ArtiXio is a global consulting and services company specializing in Regulatory Affairs, Market Access, and Pharmacovigilance for pharmaceutical, biotech, cosmetics, medical device, and dietary supplements manufacturers. Our services cover compliance, regulatory intelligence in over 70 countries, regulatory operations, post-market surveillance, commercial services, and communication strategies.

Role Description

• Client Full Representation before Chilean Health Authority (ISP), including responsibilities in GICONA's system.
• Client QA responsible in Chile.
• Product Release, (CoA, GICONA, etc.) with electronic signature.
• Interaction with Local Legal Representative (Client CL in Chile).
• Interaction with Client's LATAM RA team (BR) and Client global QA (UK).
• QC Waivers request for each imported batch.
• Interaction and coordination with third parties from Client CL for product release. <...