Spclst, Regulatory Affairs (Bogotá)

Colombia Responsibilities

• Champion promotional/non promotional materials.
• Maintenance of Life Cycle Management of the established products and transversal support within the area.
• RA Champion of the RADR system - Colombia.
• Management of archiving process in Veeva RIM within the established deadlines.
• Interaction with the HA and PAC according with the Decree 334.

Ecuador Responsibilities

• Renewal of GMPs/CPPs required by RA Ecuador.
• Tender support: Management of GMP/CPP translation process.
• Support the GMPs Registration process.
• RDAR champion for Ecuador (responsible for archiving process and process dispatches of the complete portfolio in Ecuador).
• Labeling champion for Ecuador.
• Pharmacovigilance Report Assessment.
• Maintenance of Life Cycle Management (The submission process in the HA system is not included due to technical limitations and token restr...