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Regulatory Associate

1-2 years
COP $45,000,000 – $65,000,000 annually
10 July 22, 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

Regulatory Associate – Colombia

Location: Colombia
Experience Required: 1–2 years
Job Type: Full-Time


Job Overview:
We are currently hiring a Regulatory Associate to join our growing operations in Colombia. This role involves critical data management, compliance monitoring, and regulatory support to ensure alignment with both client and internal regulatory requirements. The ideal candidate will be detail-oriented, adaptable, and capable of supporting both local and global regulatory teams in a fast-paced environment.


Key Responsibilities:

Regulatory Data Management:

  • Review and interpret data to determine system/tool population requirements based on client SOPs and business processes.

  • Perform data entry and quality control checks in regulatory systems to maintain data integrity.

  • Conduct retrospective remediation tasks to align historical data with current standards.

  • Resolve audit errors and ensure all regulatory data is accurate and complete.

Compliance & Reporting:

  • Follow quality control standards and compliance procedures to meet global regulatory expectations.

  • Generate country and regional reports as needed.

  • Provide data support during internal and external audits as part of regulatory system scope.

Stakeholder Support:

  • Collaborate with local and global team members to handle dynamic workload demands.

  • Act as a Regulatory Data SME for supported regions.

  • Identify and report data-related issues, providing practical input and solutions.


Desirable Skills and Experience:

  • 1–2 years of pharmaceutical industry experience, preferably in regulatory affairs or compliance.

  • Familiarity with regulated environments and working under compliance frameworks.

  • Intermediate to advanced English proficiency (written and verbal).

  • Experience or understanding of regulatory strategy is an advantage.

  • Strong problem-solving and analytical skills with a keen attention to detail.

  • Project coordination skills and the ability to manage multiple tasks efficiently.

  • Comfortable working both independently and within a collaborative team environment.

  • Strong technical aptitude and adaptability to learn new software, regulations, and standards.

  • Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).

  • A customer-service mindset with a focus on quality and consistency.


Estimated Salary: COP $45,000,000 – $65,000,000 annually