Remote Regulatory Affairs Specialist – Colombia & LATAM

Parexel; Colombia; Remote; COP 90,000,000 - 150,000,000; Full time

Job summary

Parexel is seeking a Regulatory Affairs professional to lead regulatory activities for Colombia from a remote location. You will manage dossiers, prepare registrations, and interact with INVIMA and LATAM authorities, ensuring timely submissions and lifecycle management for biologics and synthetic products.

You will work with global, regional, and local teams to drive regulatory excellence and navigate CTD requirements, while maintaining robust trackers and risk mitigation plans in a fast-paced

Qualifications

• Minimum 5 years of progressive Regulatory Affairs experience in pharma/biotech.
• Strong knowledge of Colombian regulatory framework and INVIMA requirements.
• Experience managing regulatory submissions and lifecycle activities for Colombia.

Responsibilities

• Prepare, compile, review, and submit regulatory applications to INVIMA.
• Manage regulatory lifecycle activities for assigned products.
• Support regulatory strategy and execution for products registered in Colombia.
• Coordinate cross-functional contributions to regulatory submissions.
• Maintain regulatory trackers and submission schedules.
• Monitor regulatory developments and communicate changes.
• Collaborate with global, regional, and local stakeholders.
• Identify regulatory risks and address operational challenges.

Skills

Regulatory affairs

INVIMA knowledge

CTD knowledge

Project management

English & Spanish fluency

Tools

INVIMA submission portal

Job description

Parexel is seeking a Regulatory Affairs professional to lead regulatory activities for Colombia from a remote location. You will manage dossiers, prepare registrations, and interact with INVIMA and LATAM authorities, ensuring timely submissions and lifecycle management for biologics and synthetic products.

You will work with global, regional, and local teams to drive regulatory excellence and navigate CTD requirements, while maintaining robust trackers and risk mitigation plans in a fast-paced