Do you have experience in regulatory affairs? Do you like administrative tasks and you enjoy planning and execution of tasks in the team? Would you like to work at the international pharmaceutical company? If yes, this might be a job for you!
Availability: Full-time (40 hours per week)
Languages: Dutch & English
Where will you work?
The company is a multinational in the pharmaceutical industry. You will be working in the Global Regulatory Affairs department that is responsible for the management of regulatory information. This will include planning, organizing, structuring, processing, reporting, archiving and ensuring compliance of information related to regulatory files, product artwork or regulatory status of the AH product portfolio worldwide.
What you will be doing?
As a Labelling Officer you will be part of the Artwork management team and is responsible for planning and execution of various tasks within the artwork management process on a daily basis.
- Responsible for maintaining the uniformity and conformity of country-specific product labelling;
- Coordinate and implement new and revised product labelling in line with regulatory product files and requested target dates in close communication with internal and external stakeholders;
- Responsible for the correct and timely control of the art-work design (internal and/or external)
- Collect 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 stakeholders e.g. Local Companies, packaging sites, Regulatory Affairs, Supply Chain Dept., Area Management, external printing, QA.
- Responsible for proper execution and documentation of new Artwork related to product introduction or changes in compliance with existing SOPs
- The Labelling Officer can have a specialized role in the artwork management process (examples: business expertise, international packaging role)
- Bachelor degree is required or proven related working experience
- Knowledge of GMP/GDP guidelines within the pharmaceutical industry;
- Previous work experience in Regulatory, QA or Supply Chain Department within the pharmaceutical industry preferred;
- Previous work experience with an artwork/document management system preferred
- Good communication skills
- Team Player
- Fluent English (speaking, reading and writing)
- Service minded
- Good attention to details
- Accurate and efficient
If you are interested in this role we look forward to receiving your application. You can send your cv and motivation to r.vanerkelens(a)jpgray.com. We will do our best to respond within 5 working days, on the off chance they we do not manage, we regret to inform we have continued with other candidates.