Regulatory dossier preparation for drug registration
Analysis of technical documentation against health legislation
Management of physical and electronic regulatory files
The job posting is for an Associate Specialist in Regulatory Affairs at a dynamic company, where the candidate will support regulatory compliance and product success. Responsibilities include preparing regulatory submissions, maintaining documentation, and ensuring alignment with health regulations
Job Summary
The role involves supporting the evaluation and preparation of dossiers for new drug registrations and renewals.
Candidates must ensure alignment with current sanitary legislation while analyzing technical documentation from global partners.
The position requires continuous monitoring of Brazilian health authority publications and assisting in regulatory intelligence activities.
Matching Summary
Match Score: 85
The job posting is for an Associate Specialist in Regulatory Affairs at a dynamic company, where the candidate will support regulatory compliance and product success. Responsibilities include preparing regulatory submissions, maintaining documentation, and ensuring alignment with health regulations.
Skills & Requirements
Must-have
Regulatory dossier preparation for drug registration
Analysis of technical documentation against health legislation
Management of physical and electronic regulatory files
Response to technical requirements from health authorities
Monitoring of Brazilian sanitary legislation updates
Labeling text creation and update (package insert)
Implementation of Standard Operating Procedures
Nice-to-have
Experience with eCTD systems
Knowledge of Good Manufacturing Practices certification
Ability to support intern monitoring activities
Strategic thinking in dynamic environments
Collaborative team player attitude
Key Requirements
Proficiency in Regulatory Applications and Compliance Audits
Experience with Document Control Systems and Data Quality Assurance
Knowledge of Electronic Common Technical Document (eCTD) standards