Regulatory Affairs Senior Associate

When our values align, there's no limit to what we can achieve.

We are looking for a Regulatory Affairs Senior Associate or Associate with 1 or 2 years of experience in MAA y MTA (marketing authorization application y marketing authorization transfers) preferably developed in CROs.

This role's main activities will be :

• Dossier management including MA submission and MA renewals.
• Perform new dossiers for new marketing authorizations (local or international).
• Handling of documentation for marketing authorization renewals and artwork managing.
• Review SmPCs and PSURs.
• Communication with local HA and clients.
• Respond to any observation from clients or local HA.
• Client facing position.
• Good English skills.