8. Специалист по регуляторным вопросам
- Deliver all activities necessary for obtaining regulatory approvals for new medicinal products, renewals and variations in order to get and maintain AZ products on the Ukrainian market.
- Prepare documentation, review and complete the processes for market specific packaging.
- Develop and maintain good relationship with Regulatory Agency at Ministry of Health in order to have timely information regarding the progress of the submitted files and regarding any changes in the setting of the authority bodies and regulation.
- Be efficient in submission process tracking. Update and maintain local and global databases in agreement with line manager.
- Ensure compliance with working practices for good regulatory practices
- Prepare and submit documentation for new medicinal products, renewals, variation, line extensions and other regulatory updates in coordination with line manager.
- To prepare license applications, renewals, line-extensions and variations within set terms.
- To assist in the drafting and reviewing labels and leaflets in support of the above applications.·
Managing registration workflow
- Plan and coordinate payments of applications for all types of regulatory activities that require payment with Finance department AZ Ukraine.
- Prepare and actively discus proposal of financial budget for Regulatory department with line manager and Financial department.
- Ensure ongoing submission process tracking as well as updating and maintaining local and global databases.
- Coordinate, supervise, prepare and submit documentation for new medicinal products, renewals, variations and line extensions.
- Maintains highest ethical standards and work in a spirit of AstraZeneca Code of Ethics, Global Regulatory Practice, following rules & norms set by corporate policies that the RAM was acknowledged about
- Ensure that all regulatory activities: Marketing Authorisation Application/New Drug Applications, Labelling Life cycle management, Health Authority interactions, Management of regulatory status information, Licence maintenance (including GMP recognition/prolongation) of specified products in compliance with Good Regulatory Practice
- Ensure all conducted activities are done in accordance with local legislation and corporate standards.
- Timely reports (as per respective procedures): health/environment/wellbeing related accidents; adverse events that you became aware about; change in status of your Conflict of Interest
- Ensure required level of knowledge and take proper personnel trainings: basic, job specific, continuing, refresher in line with assigned Role via SABA.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.