Associate Director, Regulatory Processes, AstraZeneca Gothenburg

Job description
Associate Director, Regulatory Processes - Reg Process & Compliance team, Global Regulatory Excellence

Do you have experience from regulatory affairs in the pharmaceutical industry as well as strong leadership skills? Then this might be the role for you!

In this role, you will act as technical writer and project management support to ongoing procedural. You will be working with the Processes Directors, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. You will also 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. This is a consulting assignment at AstraZeneca in Gothenburg.

Responsibilities
Support authoring and Project Management of procedural document such as Standard Operating Procedures, Work Instructions and Best Practice documentation
Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
Working with the Process Directors, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
Using deep understanding of regulatory and pharmacovigilance processes and regulations provide process or compliance 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.
Support activities required to prepare for or in response to for GVP, GCP, GRP and GMP audits/inspections
Provide process training to relevant functional groups.
Contribute to communication and change management activities associated with process initiatives.
Working collaboratively to provide expertise and sharing best practices across all regions.


Qualifications
Essential
A science/pharmacy/nursing degree, with at least 5 years 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
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.

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-09-16, 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: Linnea Öster, linnea.oster@randstad.se

About the company
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!