Regulatory Affairs Associate

Parexel

. Support preparation and coordination of local regulatory submissions, including MAAs and control changes, in accordance with ANVISA requirements .

Posted 11/11/2026full-timeRemote • BrazilJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs with a focus on ANVISA requirements, including submission preparation, compliance tracking, and documentation standards. Proficient in managing regulatory activities and ensuring adherence to local regulations in Brazil.

Highest-signal resume keywords

Regulatory Affairs ExperienceANVISA ComplianceVeeva Vault ProficiencyLabeling Requirements KnowledgeSubmission Documentation Standards

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsMarket AuthorizationsControl ChangesModule 1 DocumentationCompliance KPIs TrackingProduct Lifecycle ManagementAudit ReadinessCAPA ClosureDocumentation AccuracyRegulatory Updates Monitoring

Soft Skills

Attention to DetailOrganizational SkillsTime ManagementCross-Functional CollaborationStrong Communication Skills

Tools & Technologies

Veeva VaultMS Office Suite

Industry Keywords

Brazilian Regulatory RequirementsANVISA RegulationsPromotional Materials ReviewLocal Health AuthoritiesRegulatory Agency Expectations

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Support preparation and coordination of local regulatory submissions, including MAAs and control changes, in accordance with ANVISA requirements
Track and monitor the status of submitted regulatory activities with local health authorities
Assist in preparing module 1 documentation and other country-specific submission components
Monitor ANVISA regulatory updates and communicate relevant changes to internal teams
Support audit and inspection readiness activities and assist with timely CAPA closure
Assist in interpreting local regulations and regulatory agency expectations
Support labeling updates including SmPC, PIL, and packaging in line with local requirements
Assist in reviewing promotional materials against applicable regulations and approved labeling
Maintain and update Veeva Vault with accurate local regulatory activity and submission data
Support tracking of compliance KPIs and regulatory milestones
Support local regulatory activities related to market authorizations, product registrations, and control changes in Brazil
Ensure compliance with ANVISA requirements and support product lifecycle management at the affiliate level

Requirements

What you’ll need

At least 2–3 years of regulatory affairs experience with direct exposure to ANVISA and Brazilian regulatory requirements
Experience supporting MAAs and/or control changes
Familiarity with labeling requirements and submission documentation standards
Experience with Veeva Vault preferred
Bachelor's degree in natural sciences, pharmacy, biology, chemistry, or a related field
Knowledge of ANVISA regulations and Brazilian regulatory submission processes
Experience with Veeva Vault or similar regulatory management systems
Proficiency in MS Office suite
Strong written and verbal communication skills in English and Portuguese
Attention to detail and accuracy in documentation
Good organizational and time management skills
Ability to work effectively in a cross-functional environment

Benefits

Comp & perks

Sponsor-dedicated role
Global team environment
Opportunity to contribute to therapies benefiting patients
Work with a leading global clinical development partner
Advanced degree is a plus
Regulatory Affairs certification is advantageous (e.g., RAC or equivalent)