Our customer is one of the biggest producers of vaccines in the world. The company uses its extensive and innovative technology to combat life-threatening diseases such as Corona, HIV and Ebola.
The RA Specialist will be preparing responses to regulatory agencies' questions. Furthermore, he/she will gather and assemble information needed for submissions in accordance with regulations and relevant guidelines.
- Preparing responses to regulatory agencies' questions
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Organize and maintain reporting schedules for new drug application and investigational new drug applications
- Conducting searches of existing files for requested information
- Maintaining and archiving all regulatory documentation
- BSc or MSc in Pharmacy or relevant field
- 3-5 years of working experience in RA
- Experience in Dossier Development Module 2 and 3
- Excellent writing and communication skills in English
- Hands-on experience in documentum based systems
Are you interested and want to apply for this role? Please fill out your application via the apply button below and contact Guilherme Tokunaga