Processes Principal, Regulatory Processes, AstraZeneca Gothenburg

Job description
Processes Principal, Regulatory Processes

Do you have expertise in regulatory issues and are looking for new ways to develop? Are you highly collaborative and like to take the lead in driving process improvements? This opportunity as Processes Principal in the Regulatory Process and Compliance team might be the right opportunity for you.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Global Regulatory Excellence’s vision is to Leading enterprise wide regulatory strategies, policy and delivery - so that no patient waits. In the Regulatory Process and Compliance team we network collaboratively to enable our customer groups to operate efficient processes in a compliant manner.

Responsibilities
What you’ll do
As a Processes Principal in the Regulatory Process and Compliance team you will be working with the Processes Leads and taking responsibility for the management of assigned AstraZeneca projects-processes including implementation, communication, compliance, performance and inspection readiness. Act as technical writers and project management support to ongoing procedural document update program, including communication and training activities.
You will be accountable to execute the delivery of the processes strategy, priorities, alongside governance, authoring and lifecycle management current procedural documents. We hope that you have the drive to establish a culture of continuous improvement, high performance, flexibility and quality, emphasizing a “can do” attitude and innovative approach.

Other key responsibilities in this position:
Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
Using deep understanding of regulatory processes and regulations provide process support to regulatory teams and submissions.
Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes
Identify issues and risks and propose options to mitigate them
Provide process training to relevant functional groups.
Serve as the delegate, where appropriate, for the Process Leads
Contribute to communication and change management activities associated with process initiatives.
Working collaboratively to provide expertise and sharing best practices across all regions and in all partnerships


Qualifications
Essential for the role
A science/pharmacy/nursing degree, with relevant experience (pharmaceutical, regulatory, safety and partnership)
Experience in working cross-functionally
Leadership skills, including proven leadership of project teams experience
Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
Thorough knowledge of the drug development process
Good attention to detail
Excellent written and verbal communication skills
Proven ability to work across cultures

Desirable for the role
MSC/PhD in scientific discipline
Knowledge of new and developing regulatory and pharmacovigilance expectations
Knowledge of existing AstraZeneca external alliances and collaborative projects
Knowledge of Regulatory operating model and organisation
Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry


Application
Deadline: 2022-03-11, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information:
Please contact Birgitta Nyström birgitta.nystrom@randstad.se 

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!