AstraZeneca Pharmaceuticals LP Regulatory Information Manager in Gothenburg, Sweden
Regulatory Information Manager
Would you like the opportunity to work in a global team environment? Do you have experience of working with Regulatory Information? Are you up for a new challenge in the ever changing environment called RIMs? This might be the role you want!
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 currently looking to hire a Regulatory Information Manager to our site in Gothenburg, Sweden.
As 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. As a Regulatory Information Manager you will also be an expert in understanding Health Authority legislation interpretation as well as the regulatory requirements with regard to licenses and clinical trials aspects of tracking and life-cycle management.
To be successful in this role you 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.
• 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.
• Experience of system administration for validated applications within a regulated environment.
• Knowledge of AstraZeneca submission, publishing, approval processes, tools and standards.
• Experience in using the ANGEL 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.
If you are interested, apply now!
For more information about the position please contact hiring manager Linda Marie Jansson +46(0)317065630.
We encourage you to send your application as soon as possible, since interviews will be held continuously, but no later than November 2nd 2017.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.