You will be part of a team with the main task to ensure efficient and timely regulatory submissions directly to national health authorities, primarily for the Nordic and Baltic markets. You will mainly focus on areas in regulatory lifecycle management and provide regulatory expertise and support across organization. Our office is located in Tallinn, Estonia.
• Support activities related to product labelling and packaging material
• Prepare, update and submit the product documentation needed for registration and maintenance of our Marketing Authorisations to the Health Authorities in the region
• Communicate with Health Authorities on pending issues and changes in regulatory requirements; drive and develop key AstraZeneca specific regulatory questions and processes
• Work with defined patient safety tasks
It is essential that you:
• Have University degree in Pharmacy or equivalent
• Demonstrate experience with Regulatory work
• Can communicate in English and Estonian or other Nordic/Baltic languages
• Have good knowledge of relevant legislation requirements and procedures
• Contribute to the development of an effective team
• Ensure personal competence development
We offer you a challenging and well-aimed work in a working environment with a high organizational culture, good colleagues, a continuous professional education and a motivating salary.