Regulatory Affairs Specialist

44 minutos atrás


Brasília, Brasil Upsilon Global Tempo inteiro

Freelance Regulatory & Study Start-Up Specialist – LATAM - Brazil, Chile and Argentina

Upsilon 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 2026
Contract Length: 6 months initially
FTE: Approximately 0.5 FTE
Therapeutic Area: Observational/RWE - infectious diseases
Location: Remote, covering Brazil, Argentina and Chile

Key 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 studies
Experience managing submissions across multiple countries
Familiarity with projects including satellite sites
Proactive and solution-oriented
Strong sense of ownership and accountability
Ability to work under tight timelines
Fluency in English with Spanish/Portuguese beneficial

Experience:
EC submission expertise
Knowledge of LATAM regulatory landscapes
Hands-on experience with EC submissions in LATAM
Ability to work independently and drive submissions end-to-end
Strong coordination and stakeholder management skills

Please apply via the link, or contact /



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