I have an excellent opportunity with one of the worlds largest pharmaceutical companies in the world, as a Senior Regulatory affairs associate you will be working cross functionally with the development and commercial teams, reporting to the head of regulatory function. You will be working in the Therapeutics department, working with established licensed paediatric products, alongside 8 personnel.
The ideal candidate will have CMC experience in Post-Approval, Clinical Trial Applications, variations and SMPC updates, labelling and experience liaising with EU Markets.
Other responsibilities include:
- Good written and oral communication and networking skills. Demonstrate ability to focus and work with attention to detail.
- Demonstrate ability to retain critical information.
- Be aware of the contents of a marketing authorization application.
- Demonstrate team working and effective time management skills.
- Be a dynamic and highly motivated individual
- Establish strong relationships and liaise effectively with other sites worldwide.