For the Regulatory Affairs and Quality Assurance department of R&D in Leiderdorp, the Netherlands, we are looking for a Senior Regulatory Operations Manager.

This role is an expert in the field of document management & style compliance, regulatory submissions management & publishing and regulatory information management.

Responsibilities will include oversight of submission projects and significant interactions inside and outside the Regulatory Affairs department on complex issues and questions. Provides expertise and leadership in directing projects within assigned areas, including Regulatory Document Management, Submissions Publishing, and/or Regulatory Liaison. The position entails significant interactions with European National Competent Authorities, the European Medicines Agency and Astellas Local Affiliates. Serves on increasingly more significant project teams/task forces.

Interacts on global projects with other areas of the Astellas organization, including colleagues in the US and Japan.

 

Your personal qualifications:

• Academic level of functioning
• At least 5 years relevant experience in the pharmaceutical industry and/or with regulatory authorities,
• Good knowledge of the regulatory processes and principal dossier requirements
• Expert knowledge of document management and electronic publishing systems
• Good communication skills in a multi-cultural working environment

 

We offer:

• A challenging and diversified job
• Good career opportunities
• Inspiring work climate
• Attractive remuneration.