Trainee, Regulatory Affairs

Role Overview

• Handling of post-approval activities related to Abbreviated New Drug Applications (ANDAs) and Marketing Authorizations Applications (MAA), in specific Annual Reports and variations.
• Create Change Controls for implementation of Labeling.
• Provide information for Annual Product Review (APRs), creation, and revision of internal SOPs and DHFs whenever applicable.
• Support the site with the launch of new products, by performing all regulatory activities required.

Requirements

• Master's degree in Pharmaceutical Sciences
• 0-2 years of Regulatory Affairs experience
• Fluency in English
• Strong presentation and communication skills
• Responsibility, proactivity, and team work
• Organization and planning capabilities
• Ability to work under pressure and to meet deadlines.

Benefits

• Initial and ongoing training within a dynamic and positive environment.
• Professional development and career growth opportunities.
• The opportunity to gain knowledge and best practices within a rapidly expanding international group.