Regulatory Affairs Consultant

hace 1 semana


Ciudad de México Parexel A tiempo completo

We are currently recruiting for two Regulatory Affairs Consultant / Leads roles, one located in Mexico and the other located multi-country (Argentina o Peru or Brazil). As Regulatory Affairs Consultant / Leads, these individuals will play a pivotal role in supporting our global strategies and ensuring compliance with local regulations in their respective regions.Skills and experience:- More than 06 years in the Clinical Trial Regulatory Area.- Having experience in leading projects at the global regulatory level.- Having experience leading the regulatory team and coordinating the compilation of the Core dossiers to be submitted by the SMEs to several countries worldwide from end to end.- Experience in Central America countries will be value, but it's not mandatory.- Knowledge of EU-CTR 536/2014 (ideal).- Coordinate and manage the flow of information, track project progress, and identify and solve problems in a team-oriented environment.- Interface with the project team and the regulatory authorities on regulatory and technical matters, as appropriate.- Support the sponsor for the development of optimized clinical trial submission strategies.- Project management knowledge.- Advanced written and Speaking English.- Client-focused approach to work.- Results orientation.- Teamwork and collaboration skills Consulting skills.- Excellent interpersonal and intercultural communication skills, both written and verbal.- Critical thinking and problem-solving skills.- Proficiency in the local language.LI-REMOTE



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