Regulatory Affairs Associate - FSP

BrazilRemoteFull-timemid

Laboratory & Life SciencesRegulatory Affairs Associate

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Quick Summary

Overview

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Regulatory Affairs Associate – FSP based in Brazil.

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Laboratory & Life SciencesRegulatory Affairs Associate

We are seeking a detail-oriented Regulatory Affairs Associate to support local regulatory operations and product lifecycle activities in Brazil. In this sponsor-dedicated role, you will help coordinate regulatory submissions, market authorization applications, product registrations, and post-approval changes. You will play an important part in ensuring compliance with Brazilian health authority requirements, particularly ANVISA regulations. Working across regulatory, quality, and other internal teams, you will contribute to accurate documentation, effective submission tracking, and inspection readiness. This opportunity is suited to a regulatory professional with hands-on Brazilian regulatory experience and strong English communication skills. Your work will help support the availability and ongoing compliance of therapies that ultimately benefit patients.

Support the preparation, coordination, and submission of local regulatory applications, including Market Authorization Applications (MAAs), product registrations, and control changes, in accordance with ANVISA requirements.
Track and monitor regulatory submissions and follow up on their progress with local health authorities.
Assist in preparing Module 1 documentation and other country-specific submission components.
Monitor ANVISA regulatory updates, interpret relevant requirements, and communicate changes to internal stakeholders.
Support audit and inspection readiness activities and contribute to the timely closure of Corrective and Preventive Actions (CAPAs).
Assist with product labeling updates, including Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and packaging materials, ensuring alignment with local requirements.
Support the review of promotional materials to verify compliance with applicable regulations and approved product labeling.
Maintain accurate regulatory records and submission information in Veeva Vault or equivalent systems.
Help monitor regulatory compliance KPIs, submission timelines, and key milestones.

Requirements

~1 min read

2–3 years of experience in Regulatory Affairs, with direct exposure to ANVISA and Brazilian regulatory requirements.
Practical experience supporting Market Authorization Applications (MAAs) and/or regulatory control changes.
Knowledge of Brazilian regulatory submission processes, local labeling requirements, and submission documentation standards.
Familiarity with Veeva Vault or similar regulatory information management systems; Veeva Vault experience is preferred.
Bachelor's degree in Pharmacy, Biology, Chemistry, Natural Sciences, or a related field.
An advanced degree is an advantage.
Regulatory Affairs certification, such as RAC or an equivalent qualification, is a plus.
Advanced or fluent English, with strong written and verbal communication skills in both English and Portuguese.
Proficiency in Microsoft Office applications.
Excellent attention to detail and accuracy when preparing and maintaining regulatory documentation.
Strong organizational and time-management skills, with the ability to manage multiple activities and deadlines.
Ability to collaborate effectively with cross-functional teams and communicate regulatory information clearly.