Regulatory Affairs Associate

🔥 23 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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

• 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

• 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)

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