Assists Senior Managment in managing work and teams within a specific or broad area of site start up & regulatory , such as site activation, regulatory processes, submissions, site contracts, import & export processes and regulatory records. Ensures fulfillment of customer requirements and compliance with related regulations. Analyzes processes and develops strategies to increase efficiency.Performs operational level planning, including efficient allocation of resources within the department. Participates in the business development presentations as a subject matter expert in Site Start-Up & Regulatory functions within the Company.

Acts as a regulatory team leader on more complex projects, which may include technical writing prepares an or reviews regulatory documentation in area of expertise, as appropriate, establishes regulatory issues, present lessons learned an discuss customer comments, understand the scope of Work, deliverables and management of budget for any given project and manages workload as appropriate, give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in the training and development, present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person.Act as reviewer for regulatory SOPs, as assigned and appropriateRequired knowledge, skills and abilitiesExperience working with clinical trial submissions to both Mexican authorities and FDA, and Ethics Committees and strong written and verbal communication skills including good command of English LanguagePossesses a specific regulatory or technical expertise and strong software and computer skills, including MS Office applicationsDemonstrates self-motivation and enthusiasm, negotiation skills and is confident in making decisions whit minimal supervisionAbility to work on several projects, retaining quality and timelines and to follow SOPs consistently; provides independent thought to assist in process improvements

Revisión y aprobación de la información técnica para completar el CMC para FDAValidación y Auditorias de Información para Investigación y DesarrolloValidación de Nuevos Métodos de InvestigaciónCapacitación al Equipo de Investigación y DesarrolloManejo y Coordinación de Expedientes de Investigación