Regulatory Affairs Associate - FSP
TypeFull-time job
LocationBrazil
Posted1 hour ago
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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)
Originally posted on Himalayas
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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)
Originally posted on Himalayas
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