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    Trainee Regulatory Associate

    Novartis
    0-5 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: Trainee Regulatory Associate

    We are seeking a Trainee Regulatory Associate to join our expanding team in Colombia. This role offers an exciting opportunity to gain hands-on experience in regulatory operations and publishing.

    Core Responsibilities:

    • Publishing Support:

      • Document Management: Manage end-to-end publishing for initial IND/NDA/MAA applications and life cycle maintenance of global submissions.
      • Document Preparation: Collaborate with various departments to plan, prepare, and publish submission documents, including formatting, hyperlinking, and processing MS Word and Adobe Acrobat documents.

    • Compliance and Quality Control:

      • Regulatory Knowledge: Support the development of submission-ready documents and maintain up-to-date knowledge of agency standards and procedures for regulatory submissions.
      • Submission Formats: Support eCTD, NeES/eSub, and Paper submission formats for global agencies.
      • Quality Checks: Perform quality checks on published outputs to ensure compliance with regulatory standards and resolve any issues before submission.

    • Technical Support:

      • Troubleshooting: Address document issues with Adobe Acrobat and MS Word, and resolve gaps in submissions by collaborating with client stakeholders.
      • System Management: Review and interpret data to establish necessary systems/tools in line with SOPs and business processes. Perform data entry and quality control tasks as needed.

    • Training and Support:

      • On-the-Job Training: Provide training to beginners and colleagues, and offer QC feedback for continuous improvement.
      • Team Support: Support global/local team members with data management tasks and coordinate ancillary requests.

    • Project Management:

      • Coordination: Manage multiple requests simultaneously, ensuring deadlines are met and action dates are maintained.
      • Client Liaison: Liaise with suppliers, obtain required ancillaries/samples, and ensure timely delivery of documents to clients.

    Desirable Skills and Experience:

    • Technical Proficiency: Proficient in MS Word, MS Excel, MS Access, MS PowerPoint, and Adobe Professional.
    • Attention to Detail: Strong accuracy and attention to detail in document preparation and quality control.
    • Communication Skills: Effective communication skills for liaising with internal teams and external stakeholders.
    • Problem-Solving: Ability to troubleshoot issues and provide solutions.
    • Organizational Skills: Strong project management skills with the ability to handle multiple tasks and meet deadlines.
    • Regulatory Knowledge: Understanding of regulatory processes and compliance standards.

    This role is ideal for a proactive and detail-oriented individual eager to start a career in regulatory affairs and publishing.

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