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Regulatory Associate

1-2 years
Not Disclosed
10 Sept. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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
Location: Bogota, Colombia
Department: Regulatory Affairs
Reports To: Associate
Employment Type: Full-Time

Educational Qualification:

  • Bachelor’s degree in Pharmacy, Pharmaceutical Chemistry, or related life sciences field


Job Purpose:

Support regulatory data management and compliance activities by reviewing, interpreting, and managing data in alignment with client SOPs and business processes, ensuring quality and regulatory compliance.


Key Responsibilities:

Regulatory Data Management:

  • Review and interpret data to determine system/tools requirements in line with client SOPs and business processes.

  • Perform data entry and quality control tasks associated with regulatory systems.

  • Review audit reports and resolve errors to maintain data integrity.

  • Identify issues and provide input for solutions.

  • Perform retrospective remediation tasks as needed.

Compliance & Quality:

  • Adhere to quality control procedures and standards to ensure regulatory compliance.

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

  • Support audit activities within the regulatory data/system scope.

  • Produce country/regional reports as required.

Team Support & Collaboration:

  • Support global/local team members with data management workload when necessary.

  • Work autonomously and collaboratively in a busy environment.


Required Skills & Competencies:

  • Minimum 1–2 years of pharmaceutical industry experience.

  • Experience in a highly regulated environment.

  • Strong communication skills in English (intermediate to advanced, written and spoken).

  • Ability to work with accuracy, attention to detail, and problem-solving skills.

  • Proficiency in MS Office and other relevant software packages.

  • Customer service orientation and quality-focused mindset.

Desirable Skills & Experience:

  • Regulatory strategy experience.

  • Project management and coordination skills.

  • Technical aptitude and ability to quickly learn new software, regulations, and quality standards.

  • Self-motivated, quick learner, and able to multi-task.