Regulatory Affairs Specialist

Upsilon Global; Teletrabalho; BRL 80.000 - 120.000; Tempo parcial

Resumo da oferta

A leading regulatory consulting firm is seeking a Freelance Regulatory & Study Start-Up Specialist to manage submissions for observational studies across Brazil, Chile, and Argentina. The ideal candidate will have experience with Ethics Committee submissions, knowledge of LATAM regulatory landscapes, and be able to work independently. This role is remote and offers a contract of approximately 6 months, starting February 2026. Fluency in English is essential, with Spanish and Portuguese as a bonus.

Qualificações

• Experience with EC submissions in LATAM required.
• Proactive and solution-oriented.
• Ability to work independently and under tight timelines.

Responsabilidades

• Manage regulatory submissions and site start-up activities.
• Ensure compliance with clinical trial regulations.
• Liaise with sponsors, investigators, and ethics committees.

Conhecimentos

EC submissions for observational studies

Experience managing submissions across multiple countries

Fluency in English

Spanish/Portuguese beneficial

Strong coordination and stakeholder management skills

Descrição da oferta de emprego

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.

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

• 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 [phone] / [e-mail]

Regulatory Affairs Specialist • Recife, BR