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Regulatory Associate

Navitas Life Sciences
Navitas Life Sciences
1-2 years
Not Disclosed
Bogota, Colombia
10 March 27, 2026
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Associate | Regulatory Affairs & Data Management | Colombia

Company: Not Disclosed
Location: Colombia
Job Type: Full-Time
Work Mode: On-site / Hybrid (as per company policy)
Experience: 1–2 Years
Category: Regulatory Affairs / Clinical Research / Data Management


Job Overview

We are seeking a Regulatory Associate to support regulatory data management, compliance, and quality control activities in a highly regulated pharmaceutical environment.

This role focuses on regulatory systems, data entry, audit support, and compliance with global SOPs, ensuring accuracy and integrity of regulatory data across projects.

Ideal for professionals looking to build a career in regulatory affairs, data governance, and global compliance, this position offers exposure to international regulatory processes and systems.


Key Responsibilities

Regulatory Data Management

  • Review and interpret regulatory data to populate systems/tools as per SOPs and business processes

  • Perform data entry, validation, and quality control checks

  • Maintain accuracy and integrity of regulatory databases

Quality Control & Compliance

  • Ensure adherence to regulatory compliance standards and SOPs

  • Review audit reports and resolve data discrepancies and errors

  • Perform retrospective remediation activities

Audit & Inspection Support

  • Support internal and external audits related to regulatory systems

  • Ensure audit readiness through accurate documentation and reporting

Issue Resolution & Process Improvement

  • Identify data or system-related issues and propose solutions

  • Contribute to process improvements and regulatory efficiency

Cross-Functional Collaboration

  • Support global/local teams with data management and regulatory workload

  • Act as Regulatory Data SME (Subject Matter Expert) for supported regions

  • Generate country/regional regulatory reports


Required Skills & Qualifications

Education

  • Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field

Experience

  • 1–2 years of experience in pharmaceutical, regulatory, or clinical research roles

  • Experience working in a highly regulated environment

Technical Skills

  • Knowledge of regulatory data management and compliance processes

  • Familiarity with regulatory systems, SOPs, and audit procedures

  • Proficiency in MS Office (Excel, Word, PowerPoint)

  • Ability to quickly learn new regulatory tools and software

Core Competencies

  • Strong attention to detail and data accuracy

  • Excellent analytical and problem-solving skills

  • Good communication skills (English – written and spoken)

  • Ability to work independently and in a team environment

  • Strong organizational and multitasking abilities


Preferred Skills

  • Exposure to global regulatory submissions and compliance frameworks

  • Experience in regulatory strategy and reporting

  • Knowledge of ICH guidelines and regulatory standards

  • Experience with regulatory information management systems (RIMS)


Perks & Benefits

  • Opportunity to work in global regulatory affairs and compliance

  • Exposure to regulatory systems and international standards

  • Career growth in regulatory affairs, data management, and quality compliance

  • Collaborative and fast-paced work environment

  • Skill development in audit readiness and regulatory operations


Compensation

  • Salary Range: Not disclosed (competitive as per industry standards and experience)


About the Company

A growing pharmaceutical and healthcare solutions organization focused on delivering regulatory compliance, data management, and clinical research support to global clients, ensuring high standards of quality, accuracy, and regulatory excellence.


Call to Action

If you want to build expertise in regulatory affairs, data integrity, and global compliance systems, this is your opportunity.

Start your journey in a role that ensures accuracy, compliance, and success in global drug development.

👉 Apply now and grow your career in regulatory affairs! 🚀