Company: lupinlocation: cmx, mxjob descriptiongestionar, revisar, y proteger la documentación generada en investigación y desarrollo para la integración de expedientes técnicos para medicamentos y dispositivos médicos (nuevos registros y modificaciones).
ensure compliance with national and international standards, pharmacopoeias, and guidelines, coordinating with internal and external multidisciplinary areas during development.manage and validate the translation of required technical documentation, ensuring its integrity compared to the original documents.prepare technical justifications and respond to requests from health authorities regarding technical dossiers.verify calculations in formulation documentation, analytical development, validation, and stability studies.assign codes and manage documentation and procedures related to technical dossiers and project administration.define, plan, and monitor project activities, timelines, milestones, and responsible parties using schedules, identifying the critical path and ensuring its completion.maintain up-to-date schedules, presentations, and project and technical dossier tracking dashboards.qualifications and experiencepharmaceutical chemist, pharmaceutical engineer, chemical engineer, pharmaceutical engineer, or related fielddiploma or course in preparing technical dossiers for new registrations or mcrs according to ich guidelinesm4 - ctdknowledge of nom 059, nom 242, nom 073, nom 072, ich quality guidelines, and e6diploma or course in project management, pmi methodologies, or agile methodologiesproblem-solving, attention to detail, teamwork, assertive communication, project management, strategic relationship building3 years of experience in preparing national and international dossiers (ctd format)1 year of project management experience3 years of experience in the pharmaceutical industry#j-*-ljbffr