Regulatory Information Manager

Do you have experience of working with Regulatory Information and would like to work in a global team environment? Are you interested in a new challenge in the ever-changing environment called RIMs (Regulatory Information Management System)? Then this role is something for you!


At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We are now looking for a Regulatory Information Manager to join our team in Gothenburg, Sweden.


The Regulatory Information Team is a part of Global Regulatory Affairs that works with bringing together technology, processes and resources to enable AstraZeneca’s regulatory strategy. We maintain Regulatory Information in line with legal requirements and company objectives and oversee Regulatory systems, business processes and compliant usage to ensure that the objectives of the regulatory information are met. The RIM team partners with individual system and information owners within Regulatory to ensure the overall strategy for RIM. Another important task is partnering with our IT organization and other Business functions as well as with vendors to influence health authority and industry innovation. There is an extensive collaboration with all business units creating regulatory information across the entire value chain, from development through marketing, maintenance and pharmacovigilance.


Main duties and responsibilities
As a Regulatory Information Manager, you will be an expert in end-to-end tracking and documentation, which includes set-up, follow up and documentation of regulatory submissions and approval information. You will also be an expert in understanding Health Authority legislation interpretation as well as the regulatory requirements regarding licenses and clinical trials aspects of tracking and life-cycle management. To be successful in this role you will have to show a demonstrated ability to work collaboratively in a global team environment and have good project management skills. You need the ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment. It is important that you can demonstrate an understanding of the characteristics in building successful supplier relationships, monitors Service Level Agreements (SLAs) and manages routine quality, resource and performance issues to resolution.


Essential Requirements
Minimum 1-year hands-on experience with tracking of regulatory information
University degree or equivalent experience in life sciences or technical field
Ability to provide global expertise on requirements for tracking of regulatory submissions and approvals
Ability to assess data, documentation and processes for regulatory impact/compliance with relevant regulations and guidance and clearly communicate requirements to immediate stakeholders
Ability to use project management principles and techniques
Experience from planning of large and complex business activities
Demonstrates a broad working knowledge of process improvement methodologies, tools, techniques and their application
Excellent English written and verbal communication skills



Desirable Requirements


Experience of system administration for validated applications within a regulated environment
Knowledge of AstraZeneca submission, publishing, approval processes, tools and standards
Experience in using publishing and tracking applications
Ability to manage change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business
Good problem and conflict resolution skills