Regulatory Affairs – Marketing Authorization Application, Colombia

Parexel

. 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 .

Posted 10/22/2026full-timeRemote • ColombiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with a strong focus on Colombian regulatory requirements and INVIMA submissions. Proven ability to manage regulatory lifecycle activities, coordinate cross-functional teams, and ensure compliance with local regulations.

Highest-signal resume keywords

Regulatory Affairs ExperienceColombian Regulatory FrameworkINVIMA Submission PathwaysCTD Structure KnowledgeProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsLifecycle ManagementRegulatory DocumentationAmendments and RenewalsHealth Authority ResponsesRegulatory TrackersSubmission SchedulesRegulatory ComplianceRisk IdentificationRegulatory Strategy Implementation

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsAbility to Work IndependentlySound JudgmentCross-Functional Collaboration

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryINVIMABiologicsSynthetic ProductsVaccinesInfectious DiseasesLATAM Regulatory RequirementsElectronic Submission ProcessesCTD Format

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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