At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our peoplexceptional skills with those of people from all over the globe.
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.
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 Regulatory Information tracking tools.
- 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.
Next Steps ply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.
Date Posted 13-Feb-2018
Closing Date
