Job Description
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.
You will:
• 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
You will:
• 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
Requirements
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
• 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
Company offers
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.
Additional information
Please submit the application with CV, Letter of Motivation and desired salary conditions in English to estonia(at)astrazeneca.com no later than 26.10.2015.