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Regulatory Business Process Coordinator (Sr. Manager)

2018-10-24 Astellas Pharma Europe B.V. | Leiden | HBO | Fulltime | Sluit 2018-12-23

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

Your job as a Regulatory Business Process Coordinator
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.

Your personal qualifications as a Senior Business Process Coordinator

  • Bachelor’s degree (in scientific discipline preferred)
  • Familarity with regulations and guidances from EMA and other European agencies
  • Experience with eCTD, NEES and other technical submission formats
  • Experience with one or more European procedure types, e.g. CP, MRP/DCP
  • Experience with lifecycle maintenance, submission management and document management concepts
  • Supervisory experience
  • At least 4 years of previous industry experience; 2 in Regulatory Operations or in a role closely associated with interpretation of health authority regulations, product change control, labeling, submission publishing/dispatch, or registration tracking

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.

We offer:

  • A challenging and diversified job (example: in an international setting, or in a team of professionals)
  • Good career opportunities (if applicable)
  • Inspiring (dynamic) work climate (example: within a high tech manufacturing plant)
  • Attractive remuneration, which includes:
    • a 13th month
    • excellent pension policy
    • health insurance compensation
    • collective health insurance
    • company own saving scheme arrangement
    • 25 Holidays + 13 so called ADV Days
    • and more….

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.

About Astellas
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products.
Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
Mirai House, located in Leiden Bio Science Park, is home to a number of divisions, including the European R&D organization focusing on the development of medicines in the areas of Urology, Nephrology, Pain, and Diabetes/Metabolic diseases.

In Leiden Bio Science Park about 93 companies together with research institutes, Leiden University and the LUMC are dedicated to the development of innovative drugs, vaccines, diagnostics and platform technologies.

A VOG and/or background check can be part of the recruitment process.

Interested? Please apply via the 'Apply' button.

Agency calls not appreciated.



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