Especialista de Asuntos Regulatorios

About the role

The Regulatory Affairs Specialist will support Abbott's Established Pharmaceuticals division in Bogotá, ensuring that regulatory dossiers are accurate, up‑to‑date, and compliant with local and global requirements. The role collaborates with affiliates, quality, clinical, and TPM teams to consolidate data and manage submissions.

Key responsibilities

• Consolidate affiliate data and update regional reports using the global plan template.
• Coordinate with QA, clinical, and TPM teams to gather required modules for dossier preparation.
• Maintain the regulatory database and 2024 plan, reflecting approvals and submissions.
• Upload, validate, and monitor dossiers in the DARIUS system, ensuring correct activity creation and documentation.
• Verify product listings, Planisware numbers, and marketing status in DARIUS.
• Support affiliates with TPM dossiers, LLCR creation, and CCDS/RL updates.
• Monitor change controls, deviations, and risk‑assessment updates for labeling distribution.

Required profile

• Based in Bogotá, Colombia, with experience in pharmaceutical regulatory affairs.
• Ability to work cross‑functionally with affiliates and internal teams.
• Attention to detail and strong organizational skills for database management.

Required skills

• Proficiency with the DARIUS regulatory submission system.
• Experience using Planisware (ATOM/RAPTOR) for product tracking.
• Knowledge of regulatory database maintenance and CFR product reporting.
• Familiarity with TPM dossier preparation and LLCR/CCDS updates.

What we offer

• Career development within a global healthcare leader.
• Recognition as a top employer for diversity and inclusion.
• Opportunities to work on a broad portfolio of branded generic medicines.