Regulatory Affairs Specialist

MSD in Boxmeer is looking for a temporary Labelling Officer to join their Global Operations Affairs team.

Global Regulatorily Affairs Operations is part of Global Regulatory Affairs Animal Health (AH). This department is responsible for the entire regulatory data and document infrastructure electronic publishing of registration dossiers and management of the related labeling for the AH product portfolio.

The Labelling Officer function its main task is to operate the artwork management process on a daily bases.

Main tasks:

• Coordinate small artwork management projects with minimal guidance from the Labeling Coordination. Participates in change teams and can support the Labelling Coordination in PIT teams.

• Collecting all necessary information for the preparation of new product labelling, such as technical specifications, design specifications, registration requirements and texts.

• Responsible for proper phasing of the modified materials and control of phasing out of the existing packaging materials.

• Maintain contacts with all major stakeholder e.g. Local Companies, packaging sites, Regulatory Affairs, Supply Chain Dept., Area Management, external printing, QA.

• Responsible for the daily planning of the operational tasks of the labelling team

• Is Subject Matter Expert for more than one topic within the artwork management discipline (e.g. pack site, global topic on downstream artwork management processing, work process, business expertise).

Job requirements

• Bachelor degree is required or proven related working experience

• Preferably gained work experience in Regulatory, QA or Supply Chain Department within the pharmaceutical industry.

• Preferably experience working with an artwork/document management system

• Preferably experience with GMP guidelines within the pharmaceutical industry.

• Fluent English (speaking, reading and writing).

This position is temporary, more details can be provided after application.