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
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

Your profile
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

About the organisation
This position is a consultant assignment at AstraZeneca via QRIOS Life Science & Engineering in Göteborg for six months. During this time you will be employed by QRIOS Life Science & Engineering.
QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER

Why AstraZeneca?
Our Gothenburg site is one of AstraZeneca's three strategic R&D centers. With more than 2,400 employees from over than 50 countries, our vibrant Gothenburg site is a truly inspiring place to work. Here, the history and future of scientific breakthrough come together. We believe that the diversity of our people is crucial to bringing new discoveries to life.