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A large Global pharmaceutical company is currently looking for a Senior Regulatory Operations Manager to join their Global headquarters in Netherlands. To find out more about the company and position call Nikolay on +44 (0)207 255 6665 or e-mail Nikolay.email@example.com
As a Senior Regulatory Operations Manager you will be an expert in the field of document management and style compliance, regulatory submissions management & publishing and regulatory information management.
-Supervision of submission projects and significant interactions inside and outside the Regulatory Affairs department.
-Provide expertise and leadership in directing projects within assigned areas, including Regulatory Document Management, Submissions Publishing, and/or Regulatory Liaison.
-Significant interactions with European National Competent Authorities, the European Medicines Agency and Local Affiliates.
-Interact on global projects with other areas of the organization, including colleagues in the US and Asia.
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
This is a fantastic opportunity to work for a global pharmaceutical player that offers a challenging and diversified job, great career opportunities, inspiring work climate and attractive remuneration!
Keywords: Regulatory Operations, Regulatory Operations Manager, document management, style compliance, regulatory submissions management, publishing, regulatory information management
+44 (0)20 7255 6665
+49 (0)69 222 22 888
+41 (0)44 580 3717