Senior Analyst, Regulatory Affairs responsible for regulatory strategy and compliance within AES. Collaborating with various stakeholders to ensure RTO/ISO compliance and market strategies.
About the role
- Analista de Assuntos Regulatórios supporting regulatory strategies for multinational pharmaceutical company. Involves management of drug registration processes and performance monitoring in São Paulo.
Responsibilities
- Support the Regulatory Affairs Manager in implementing regulatory strategies
- Support applications for new registrations of biological and synthetic medicines (gap analysis, preparation of technical reports, review of labeling and package inserts, etc.)
- Prepare and manage submissions throughout the product lifecycle
- Monitor the Department's Key Performance Indicators (KPIs)
- Manage contracts and purchase orders related to the department's service providers
- Manage reviews and approvals of promotional materials
Requirements
- Bachelor's degree
- Advanced English, capable of conducting meetings in English
- Experience in regulatory affairs within a multinational pharmaceutical company
Benefits
- Permanent employment with a multinational pharmaceutical company
- Hybrid work (office and remote)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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