Overview

Responsibilities:


- Takes responsibility for assigned tasks and/or projects
- Has working knowledge of EU regulations within a specified area: medicines, cosmetics and medical devices
- Specialized knowledge level, with sufficient experience and skill to execute under general supervision
- Ensures compliance within the department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to
- Updates relevant global, regional and local databases to ensure compliance
- Reviews artwork and promotional copy material to ensure regulatory compliance with local regulations
- Uses available electronic publishing tools to compile, electronic or paper based submissions necessary to meet regulatory requirements
- Maintains and archives regulatory documentation (as appropriate)
- Organizes and maintains reporting schedules
- Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
- Conducts searches of existing files for requested information
- Ensures quality and compliance in all actions
- Task oriented; Executes under direction of an expert or manager

Required Qualifications:


- Graduated in Life Science (Pharmacology, Chemistry, Biology, Medicine), new graduates and last grade students are especially welcome
- Experience in related field is a plus
- Knowledge and experience in EU regulations is a plus
- Fluent in English (writing and speaking)
- Appropriate knowledge of Spanish or Portuguese (writing and speaking)
- Availability for full time work
- Ability to work under pressure to meet the deadlines
- Ability to get a challenge and perform excellent team work