vacature regulatory-affairs

Regulatory Business Process Coordinator (1,0 FTE)

  • Tijdelijk dienstverband
  • Leiden, Nederland
  • Referentienummer: DT/19-110-DD

Derks & Derks Detachering

Temporary position as a regulatory professional for at least 12 months in the pharmaceutical industry

Offer

  • diverse job within a pharmaceutical company
  • interesting job because of the work on specific projects
  • temporary contract with the possibility to extend

Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is in Leiden, but has tight lines around the world. For the Global Safety Science department they are looking for support. Therefore, they would like to meet an experienced Regulatory Business Process Coordinator with heavy project management skills on a global level.

Position

As a Regulatory Business Process Coordinator you are responsible for the coordination of the collection, organization and dissemination of submissions and related regulatory information. This is essentially a submission manager role that provides broader visibility to changes in the regional or in some cases global product portfolio and is the central point of knowledge related to operational status and execution responsibilities. You identify changing regulatory guidance and anticipate impact on submission preparation and processing other information management activities. While managing multiple projects you accurately document change and ensure all approval requirements are met before releasing product quality, patient safety, and in some cases, product sales.

As a Regulatory Business Process Coordinator your focus is on the EMEA region; but you will liaise with global colleagues, senior management and Global Project Teams. You address complex and diverse challenges with decision-making that impacts multiple projects, functional areas and therapeutic areas. Within the organization you are the person whom others can ask about submission plans and other operational aspects of a product or product portfolio. In the position you will report to the manager of the department.

Profile

  • Bachelor’s degree (scientific discipline preferred)
  • At least 3 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
  • Familiarity with one or more key regional Health Authority regulations, interpreting regulatory guidance and monitoring the external regulatory environment for changes that impact submission standards or other regulatory practices
  • 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

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-110-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

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