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Regulatory Associate

1-2 years
Not Disclosed
10 June 24, 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 – Colombia


Job Summary:

A leading pharmaceutical company is hiring a Regulatory Associate to manage regulatory data and ensure compliance across global systems. This role involves handling data entry, quality control, audits, and regulatory reporting, ensuring integrity and adherence to compliance standards. Ideal for professionals with a background in regulatory affairs and data management.


Key Responsibilities:

  • Review and interpret regulatory data to determine system/tool requirements as per client SOPs.

  • Perform data entry and quality control for regulatory systems.

  • Review audit reports, identify errors, and resolve discrepancies to maintain data accuracy.

  • Execute retrospective remediation tasks when required.

  • Adhere to established quality control procedures ensuring regulatory compliance.

  • Support local/global teams by managing regulatory data workloads flexibly.

  • Act as a subject matter expert (SME) for regulatory data within the supported regions.

  • Generate country/regional regulatory reports as needed.

  • Assist in regulatory audits as part of data/system scope.


Required Skills & Qualifications:

  • 1–2 years of pharmaceutical industry experience in a regulated environment.

  • Strong understanding of regulatory compliance and data integrity principles.

  • Proficient in English (intermediate to advanced) – both written and verbal.

  • Regulatory strategy exposure preferred.

  • Ability to work independently and collaboratively in a dynamic team setting.

  • Excellent attention to detail with strong problem-solving abilities.

  • Project coordination and time management skills.

  • Quick learner with the ability to grasp new software and regulatory standards.

  • Proficiency in MS Office tools and other regulatory software.

  • Customer service and quality-focused mindset.


Perks & Benefits:

  • Competitive compensation package (not specified).

  • Exposure to global regulatory systems and processes.

  • Professional development and learning opportunities.

  • Supportive and collaborative work culture.


Company Description:

A globally recognized pharmaceutical leader offering innovative healthcare solutions. The company is known for maintaining high regulatory standards and ensuring data integrity across international markets, fostering career growth in regulatory affairs.


Work Mode:

On-site – Colombia


Call to Action:

Ready to enhance your regulatory career with a leading pharmaceutical company? Apply now to join as a Regulatory Associate and contribute to global healthcare compliance.