Are you a strong organized, regulatory affairs professional with experience in key regional health authority regulations? Are you able to play a key role in an international organization and define and support the submission portfolio management process across multiple products and therapeutic areas? Then Astellas has an interesting job opportunity for you!
Regulatory Business Process Coordinator (Sr. Manager)
40 hours, Leiden, The Netherlands
The Senior Regulatory Business Process Coordinator is responsible for the coordination of the collection, organization and dissemination of submissions and related regulatory information. This is a key role who provides broader visibility to changes in a regional or global product portfolio and is the central point of knowledge related to operational status and execution responsibilities of those products. You identify changing technical guidance and anticipate impact on submission preparation and other information management activities. Within managing multiple projects you accurately document registration changes and ensure all approval requirements are met before submitting.
In this position your focus is on the EMEA region but you will liaise with global colleagues, senior RA management and Global Project Teams. You address complex and diverse challenges with decision-making that impacts multiple projects, functional areas and therapeutic areas. It is necessary to actively identify and advocate for the optimal solution. Within Astellas you are the person whom others can consult to obtain answers to complex questions regarding submission-related regulations and guidelines.
You are a disciplined project manager and are able to track various tasks and regulatory requirements. Success will be measured in part by the timeliness and accuracy of submissions and other internal process steps. The role expects collaboration and effective communication. You are able to influence peers and others within the organization. As a coordinator you have strong organizations skills, a high level of attention to detail and you are able to manage multiple diverse projects simultaneously.
At Astellas, we believe that nurturing a good relationship with our employees delivers good business results.
It is our stated aim in the VISION for Astellas to be recognised as an Employer of Choice. This means ensuring we are a highly effective organisation, that applies best-in-class people management, creates a positive working environment and has an inspirational company culture.. This reflects the working culture of Astellas, outlines our expectations as an employer and captures the essence of our company ethos; CHANGING TOMORROW.