Regulatory Affairs Analyst – Pharmaceutical

About the role

We are looking for a Regulatory Affairs Analyst specialized in pharmaceutical translation management for LATAM markets. The role ensures that regulatory changes are accurately reflected in the SCF system and that all artwork complies with approved specifications.

Key responsibilities

• Implement changes required through DCIs in the SCF and verify alignment with approved artwork.
• Validate that SCF modifications correspond to LRAM DCI requests and comply with LATAM regulations.
• Assess multi‑country impact of changes and coordinate alternative solutions with affected LRAMs.
• Develop implementation plans together with the LCM.
• Use SAP, Veeva Vault and TVT Backup for translation management activities.
• Coordinate dossier translation, retrieve and process editable documents for translation.
• Manage translation for maintenance events, renewals, CMC and CCDS submissions.
• Perform technical validation of received and translated documentation, maintaining traceability trackers.

Required profile

• Experience in regulatory affairs with solid knowledge of current LATAM guidelines.
• Bachelor’s degree in Pharmacy, Medicine, Chemistry or a related life‑science discipline.
• Advanced proficiency in English.
• Strong understanding of LATAM regulatory requirements.

Required skills

• SAP
• Veeva Vault
• TVT Backup