Regulatory Affairs Specialist

Há 12 horas


Belo Horizonte, Brasil Upsilon Global Tempo inteiro

Freelance Regulatory & Study Start-Up Specialist – LATAM - Brazil, Chile and ArgentinaUpsilon Global are seeking a freelance regulatory and start-up specialist with solid experience in Ethics Committee submissions for observational studies in LATAM, specifically Chile, Argentina and Brazil.The role will provide centralized oversight and execution of local submissions across the three countries to ensure quality, consistency and timeline adherence.Key Details:Start Date:February ****Contract Length:6 months initiallyFTE:Approximately 0.5 FTETherapeutic Area:Observational/RWE - infectious diseasesLocation:Remote, covering Brazil, Argentina and ChileKey Responsibilities:Manage regulatory submissions and site start-up activities.Ensure compliance with Swiss and international clinical trial regulations.Liaise with sponsors, investigators, and ethics committees.Track approval timelines and maintain regulatory documentation.Provide guidance on regulatory requirements and study compliance.Requirements:EC submissions for observational studiesExperience managing submissions across multiple countriesFamiliarity with projects including satellite sitesProactive and solution-orientedStrong sense of ownership and accountabilityAbility to work under tight timelinesFluency in English with Spanish/Portuguese beneficialExperience:EC submission expertiseKnowledge of LATAM regulatory landscapesHands-on experience with EC submissions in LATAMAbility to work independently and drive submissions end-to-endStrong coordination and stakeholder management skills



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