Parexel FSP is seeking Regulatory Affairs Associates to join our Team in Brazil. This is a sponsor dedicated role. Candidates should have at least 2-3 years of experience and advanced/fluent english.
About Parexel
Parexel is a leading global clinical development partner delivering insights‑driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient‑focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.
About the Role
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
Skills
- 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
Knowledge and Experience
- 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)
#LI-REMOTE
