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    Regulatory Associate

    Navitas Life Sciences
    1-2 years
    Not Disclosed
    Bogota
    10 July 26, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Description: Regulatory Associate

    We are seeking a Regulatory Associate to join our expanding team in Colombia. In this role, you will ensure the accurate and compliant management of regulatory data and systems, supporting both local and global teams.

    Core Responsibilities:

    • Data Management:

      • System and Tools: Review and interpret data to determine the necessary systems/tools for compliance with client SOPs and business processes.
      • Data Entry: Perform data entry and quality control tasks to ensure the accuracy and integrity of regulatory systems.

    • Quality Control and Compliance:

      • Audit Resolution: Review audit reports, address errors, and resolve issues to maintain data integrity.
      • Compliance Adherence: Follow quality control procedures and standards to ensure regulatory compliance.

    • Issue Resolution and Support:

      • Problem-Solving: Identify issues and contribute to solutions.
      • Remediation: Perform retrospective remediation tasks as needed.
      • Team Support: Provide flexible support to global/local team members with data management tasks.

    • Reporting and Coordination:

      • Reporting: Produce country/regional reports as required.
      • Audit Support: Assist with audits related to regulatory data and systems.

    Desirable Skills and Experience:

    • Experience: 1-2 years in the pharmaceutical industry, preferably in a highly regulated environment.
    • Communication: Intermediate to advanced proficiency in English (both written and spoken).
    • Regulatory Knowledge: Experience in regulatory strategy and compliance.
    • Technical Skills: Proven ability to quickly learn and use new software, regulations, and quality standards.
    • Attention to Detail: Strong accuracy and attention to detail.
    • Problem-Solving: Effective problem-solving skills with the ability to address and resolve issues.
    • Project Management: Project management and coordination skills with the ability to work autonomously and as part of a team.
    • Technical Aptitude: Proficiency in MS Office and other software packages.
    • Customer Focus: Customer service and quality-focused approach.

    This position is ideal for a motivated individual who thrives in a fast-paced environment, with strong attention to detail and a commitment to regulatory excellence.

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