Analista Documentação Técnica Regulatória Pleno (Sede: Itapevi/SP)
Core
Prepare and review regulatory documentation for local and export product registrations, renewals, and post-registration changes, ensuring compliance with health authority compendia and regulations.
Role type
Regulatory Affairs Technical Documentation Specialist
Builds
Regulatory submissions and documentation packages for pharmaceutical products
Domain
Pharmaceutical industry / Regulatory Affairs
Required skills
Pharmaceutical regulations knowledge, Technical documentation, Change control management, SOP development, SAP system proficiency, Controlled substance reporting, Analytical validation concepts, Office tools
Preferred skills
Spanish language, Training and mentoring, Process improvement, Data analysis
Technologies
SAP, e-PALMS
Responsibilities
Prepare and review documentation for new and renewed product registrations, manage post-registration changes and impact assessments, maintain legal documents for regulatory inspections, monitor regulatory compendia and updates, approve artwork for compliance, develop and review standard operating procedures, prepare reports for controlled substances.
Seniority
Mid-level (2-4 years experience)
