Instagram
youtube
Facebook

Regulatory Associate

1-2 years
Not Disclosed
10 May 28, 2025
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

 

Job Title: Regulatory Associate


Job Overview

We are currently seeking a Regulatory Associate to join our growing team in Colombia. The role is focused on supporting regulatory data management, ensuring compliance, and providing quality support across systems and tools aligned with client standards and processes.


Key Responsibilities

  • Review and interpret data to determine the appropriate systems/tools for population in accordance with client SOPs and business process documentation

  • Perform data entry and quality control tasks in regulatory systems

  • Review audit reports, resolve errors, and ensure data integrity

  • Identify and troubleshoot data-related issues and contribute to problem resolution

  • Perform retrospective remediation tasks as assigned

  • Follow established quality control procedures and standards to maintain regulatory compliance

  • Provide support to global/local teams with regulatory data management tasks as needed

  • Serve as a Regulatory Data SME (Subject Matter Expert) in supported regions

  • Generate country/regional reports as required

  • Participate in and support audits related to regulatory data/system scope

  • Ensure adherence to internal and external compliance standards


Desirable Skills and Experience

  • 1–2 years of experience in the pharmaceutical industry

  • Experience working in highly regulated environments

  • Intermediate to advanced English proficiency (written and spoken)

  • Exposure to regulatory strategy is a plus

  • Ability to work independently and collaboratively in a fast-paced environment

  • High attention to detail and accuracy

  • Strong problem-solving and project coordination skills

  • Quick learner with strong technical aptitude and the ability to adapt to new software, regulations, and quality standards

  • Proficiency in Microsoft Office and other relevant software

  • Customer service orientation with a focus on delivering quality