Sanofi is seeking a Regulatory Affairs Analyst to ensure compliance of its product portfolio with ANVISA regulations in Brazil. The role involves managing regulatory processes, collaborating with various internal teams, and monitoring legislative changes to facilitate product access in the market
Job Summary
The Analista de Assuntos Regulatórios Pl. is responsible for ensuring the compliance of Medley's product portfolio with ANVISA, leading registration, renewal, post-registration changes, and responses to regulatory requirements.
This role involves collaborating with various departments such as Quality, Pharmacovigilance, Operations, and the Campinas factory, as well as conducting competitive intelligence and monitoring Brazilian regulatory legislation.
The position offers the opportunity to be part of a dynamic regulatory team with a high volume of projects and the chance to develop expertise in the Brazilian regulatory environment.
Matching Summary
Match Score: 85
Sanofi is seeking a Regulatory Affairs Analyst to ensure compliance of its product portfolio with ANVISA regulations in Brazil. The role involves managing regulatory processes, collaborating with various internal teams, and monitoring legislative changes to facilitate product access in the market.
Skills & Requirements
Must-have
ANVISA regulatory compliance
product registration processes
post-registration changes
regulatory intelligence
promotional material evaluation
Nice-to-have
strategic link between regulatory demands
collaborative work environment
dynamic and results-oriented culture
Key Requirements
Experience in the pharmaceutical industry in Regulatory Affairs
Knowledge of Brazilian sanitary legislation and ANVISA processes
Experience in registration, renewal, and post-registration changes for generic and similar synthetic drugs
Experience in monitoring and interfacing with regulatory authorities