Ctry Approval Spec

Thermo Fisher Scientific

Full time São Paulo, State of São Paulo Business Operations Specialists

Posted:

February 25, 2026

Location:

São Paulo, State of São Paulo, Brazil

Job Description

Prepares, reviews and coordinates, under guidance, regulatory submissions to EU CTIS ( and additional special national local applications if applicable, gene therapy approvals) in alignment with global submission strategy;
Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients;
May have contact with investigators for submission related activities;
Key-contact at country level for either Ethical or Regulatory submission-related activities;
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation;
Achieves PPD’s target cycle times for site;
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable;
May de...
                

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Job Overview

Job Type: Full time

Location: São Paulo, Brazil

Posted: February 25, 2026

Deadline: April 06, 2026