Associate Director, Regulatory Processes
Location: Cambridgeshire, Cheshire East
Job Type: Full time
Do you have expertise in regulatory matters and are looking for new ways to develop? Are you highly collaborative and like to take the lead in driving process improvements? Then this position as a Associate Director Processes 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.
What you’ll do
As an Associate Director Processes 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. You will be accountable to develop relationships across Regulatory Affairs and other relevant areas of AZ to execute the delivery of the processes strategy, priorities, alongside governance and management of the current procedural documents. We hope that you have the drive to establish a culture of continuous improvement, high performance, flexibility and quality, emphasising 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.
Coordination and ownership of the lifecycle management of nominated processes, enabling business continuity and compliance.
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 and partnerships.
Identify issues and risks and propose options to mitigate them
Contribute to monitoring, interpretation and validation current, new and changing legislation, and manage the impact of changes.
Deliver on project assignments supporting the business, e.g., representation or leadership on global cross-functional task forces.
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
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
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
We are screening applications on an ongoing basis therefore please apply as soon as possible, and no later than , 7 October, 2022. Welcome to apply!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.