Regulatory Affairs – Marketing Authorization Application, Colombia

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Prepare, compile, review, and submit regulatory applications along with supporting documentation to INVIMA, which includes new registrations, variations, renewals, supplements, amendments, and responses to inquiries from health authorities.

• Oversee regulatory lifecycle activities for assigned products, ensuring adherence to local regulatory requirements and timelines.

• Assist in implementing regulatory strategies and executing operations for products that are registered in Colombia.

• Coordinate contributions from various functions to regulatory submissions while ensuring the completeness and quality of the dossiers.

• Maintain regulatory trackers, submission schedules, and documentation to guarantee accurate status reporting and timely execution.

• Monitor regulatory developments and communicate pertinent changes that may affect products or regulatory activities.

• Collaborate effectively with global, regional, and local stakeholders to provide regulatory support and promote project deliverables.

• Identify potential regulatory risks, proactively address operational challenges, and escalate strategic or authority-sensitive issues as necessary.

⛳️ Requirements

• A minimum of 5 years of progressive experience in Regulatory Affairs within the pharmaceutical or biotechnology sector.

• Proven regulatory expertise in supporting products within Colombia.

• Strong understanding 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 in preparing and managing regulatory submissions, amendments, renewals, supplements, and responses to inquiries from health authorities.

• Strong grasp of CTD structure, format, and content requirements.

• Experience in authoring, reviewing, and coordinating regulatory documentation across multiple functions.

• Ability to thrive in a cross-functional, matrix environment while managing various priorities and deadlines.

• Strong organizational and project management skills with a proven track record of managing regulatory timelines and deliverables.

• Demonstrated capacity to work independently, exercise sound judgment, and take ownership of regulatory activities.

• Experience with vaccines, biologics, infectious diseases, or other complex products is an advantage.

• Exposure to regulatory requirements in other LATAM countries is desirable.

• Excellent verbal and written communication skills in both English and Spanish.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance coverage.

• Opportunities for professional development and career advancement.

• Collaborative work environment with a focus on innovation.