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 the organization. The role is based at our office in Tallinn, Estonia.
• 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
• Support activities related to product labelling and packaging material
• Have the responsibility for applications for new products and variations for established products supporting rapid and high quality approval in all Nordic Baltic area
• Be involved in submissions of clinical trial applications as needed.
It is essential that you:
• Have University degree in Pharmacy or equivalent
• Demonstrate experience with Regulatory work
• Can communicate in English and Estonian, skills in other Nordic/Baltic languages are an advantage
• Have a 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.