Regulatory Affairs Analyst - Translation Management, Artwork Review and Change Management

About the role

Genpact is looking for a Regulatory Affairs Analyst focused on translation management, artwork review and change management. The role ensures that changes required through DCIs are properly implemented in the SCF and that there are no discrepancies with the approved artwork, working mainly with LATAM countries.

Key responsibilities

• Ensure DCI-required changes are correctly implemented in the SCF and that they match the approved artwork; verify that SCF changes relate to the LRAM's DCI request and that additional changes comply with regulations.
• In multi-country presentations, evaluate the impact of changes on the affected countries and, where applicable, align alternative solutions with the LRAMs of those countries.
• Develop the implementation plan together with the LCM.
• Use software and systems such as SAP, Veeva Vault and TVT Backup for translation management activities.
• Coordinate dossier translations, including retrieving and processing editable documents, and coordinate translation for maintenance events, renewals, CMC and CCD.
• Technically validate received documentation and translated documents (formatting, excluding content checks).
• Maintain traceability trackers.

Required profile

• Experience in regulatory affairs with knowledge of current LATAM market guidelines.
• Bachelor's degree, preferably in Pharmacy, Medicine, Chemistry or another life science discipline, with relevant pharmaceutical industry experience.
• Advanced level of English.
• Knowledge of LATAM regulations is mandatory.

Required skills

• SAP, Veeva Vault and TVT Backup for translation management.
• Technical validation of documents and traceability tracking.