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.Reviews of critical key technical documents (e.g. clinical trial protocols and reports, study drug labels, and other clinical trial-related technical documentation) to ensure regulatory compliance for clinical trial applications, consistency with other key documents and ease of review.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.
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