Regulatory Affairs – Marketing Authorization Application, Colombia

• Prepare, compile, review, and submit regulatory applications and supporting documentation to INVIMA, including new registrations, variations, renewals, supplements, amendments, and responses to health authority requests
• Manage regulatory lifecycle activities for assigned products, ensuring compliance with local regulatory requirements and timelines
• Support regulatory strategy implementation and operational execution for products registered in Colombia
• Coordinate cross-functional contributions to regulatory submissions and ensure the completeness and quality of dossiers
• Maintain regulatory trackers, submission schedules, and documentation to ensure accurate status reporting and timely execution
• Monitor regulatory developments and communicate relevant changes that may impact products or regulatory activities
• Collaborate closely with global, regional, and local stakeholders to provide regulatory support and drive project deliverables
• Identify potential regulatory risks, proactively address operational challenges, and escalate strategic or authority-sensitive matters as needed

• Minimum of 5 years of progressive Regulatory Affairs experience within the pharmaceutical or biotechnology industry
• Proven regulatory experience supporting products in Colombia
• Strong knowledge of the Colombian regulatory framework and INVIMA requirements for biologics and synthetic products, including registration and lifecycle management activities
• Familiarity with INVIMA submission pathways, administrative requirements, and electronic submission processes is highly preferred
• Demonstrated experience preparing and managing regulatory submissions, amendments, renewals, supplements, and responses to health authority questions
• Strong understanding of CTD structure, format, and content requirements
• Experience authoring, reviewing, and coordinating regulatory documentation across multiple functions
• Ability to successfully work in a cross-functional, matrix environment while managing multiple priorities and deadlines
• Strong organizational and project management skills with a proven ability to manage regulatory timelines and deliverables
• Demonstrated ability to work independently, exercise sound judgment, and take ownership of regulatory activities
• Experience with vaccines, biologics, infectious diseases, or other complex products is considered an advantage
• Exposure to regulatory requirements in other LATAM countries is desirable
• Excellent verbal and written communication skills in both English and Spanish