Job Title - Regulatory Affairs Specialist
Global data management and labelling is part of global regulatory affairs AH. This department is responsible for the entire regulatory data and document infrastructure electronic publishing of registration dossiers and management of the related labelling for the AH product portfolio.
Global data and labelling management AH is looking for a:
Regulatory affairs labelling officer
- Responsible for guarding the uniformity of country-specific product labelling, achieving deadlines, target dates and internal and external communication;
- Coordination and implementation of new and revised product labelling in line with regulatory product files;
- Responsible for the correct and timely control of the art-work design department (internal and/or external)
- 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 correct/complete intake of the documents and procedure that trigger initiation of introductions / changes
- Preferably gained work experience in Regulatory, QA or Supply Chain Department within the pharmaceutical industry;
- 3-5 years of relevant experience
- Bachelor degree is required
- Preferably experience working with an artwork/document management system
- Preferably experience with GMP guidelines within the pharmaceutical industry;
- Good communication skills.
- Team Player
- Fluent English (speaking, reading and writing)
- Service minded
- Accurate and efficient
If this position is something that you want to do, and if you believe you have the right qualifications and experience required for the role, please do not hesitate and send us an e-mail with your most recent CV and motivational letter to: j.vanbaalen(@)progressive-nl.com