[Hiring] Regulatory Affairs Associate @Parexel

Role Description

The Regulatory Affairs Associate supports local regulatory activities related to market authorizations (MAA), product registrations, and control changes in Brazil. The role ensures compliance with ANVISA requirements by preparing submissions, maintaining regulatory records, and supporting product lifecycle management at the affiliate level.

Key Accountabilities:

• Regulatory Submissions and Lifecycle Management:
  • 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.
• Regulatory Compliance and Intelligence:
  • 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.
• Labeling and Promotional Materials:
  • Support labeling updates including SmPC, PIL, and packaging in line with local requirements.
  • Assist in the review of promotional materials against applicable regulations and approved labeling.
• Regulatory Systems and Reporting:
  • Maintain and update Veeva Vault with accurate local regulatory activity and submission data.
  • Support tracking of compliance KPIs and regulatory milestones.

Qualifications

• 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.

Requirements

• 2 to 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.

Education

• Bachelor's degree in natural sciences, pharmacy, biology, chemistry, or a related field.
• Advanced degree is a plus.
• Regulatory Affairs certification is advantageous (e.g., RAC or equivalent).