Regulatory Affairs Associate

hace 3 semanas


Desde casa, México ProductLife Group A tiempo completo

In the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico.**Responsibilities**:Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.Contribute to the production of client administrative documents to be included in regulatory submissionsCompile regulatory dossiers in accordance with national requirements.Systems Management and AdministrationDocument and track regulatory submissions and regulatory authority approval.Provide regulatory support to clients and associate companiesLiaise with sponsor head-office and affiliate departments on regulatory issues.Provide review of packaging texts.Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory servicesEducation & ExperienceBachelor’s or higher graduate degree in a science related field, or equivalent experience1 to 3 years of experience in Regulatory AffairsExperience in LATAM region regulationsProfileHard/Technical skills:Knowledge of LATAM regulationsGood understanding of regulatory tracking database software, eDMS, MS Word, MS ExcelSoft skills:Excellent organizational and interpersonal skillsAbility to work well within a teamProcess oriented with good attention to detailEffective oral and written communication skillsSense of responsibility and meeting deadlinesFluency in SpanishGood command of English



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