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Regulatory Affairs Industrial Placement
- To help ensure that existing UK Product Licences are maintained and new Marketing Authorisations are obtained to allow continued and future sale of categories of Consumer Healthcare products in the UK.
- To help ensure that all regulatory activity for a specified portfolio of products is planned and geared to commercial requirements.
- To help ensure that all cosmetic products are sold in compliance with the Cosmetics Directive, that all medical devices are sold in compliance with the Medical Device Directives and that all pack and promotional copy complies with regulations and Codes of Practice.
- To have responsibility with the support of a Regulatory Category Manager for projects involving marketed and development products and to be responsible for progressing the regulatory status of these products in the UK in such a manner as not to interfere with the marketing and the development activities of the business.
- To have a general understanding of the regulatory environment.
- To prepare submissions which are both accurate and high quality and ensure all files and databases are effectively managed.
- To maintain relationships with regulatory authorities to expedite smooth and timely assessment of all applications.
- To be responsible with the support of a Regulatory Category Manager for advising marketing and Global Manufacturing and Supply on the regulatory implications of technical changes
- To develop knowledge of the regulations and guidelines and working practices of the EC and UK Regulatory Authority.
- To develop some knowledge of the Cosmetics Directive and PIPs, and Medical Devices Directive if relevant to the category.
- Ability to prioritise work load
- Demonstrate ability to show attention to detail
- Good customer focus and team
One of the world’s leading healthcare companies, GSK discovers, develops, manufactures and distributes life-saving vaccines, prescription medicines and consumer health products such as Maxinutrition, Sensodyne, Aquafresh and Panadol.
The size and scope of our organisation allows our people to answer some of the biggest questions facing everyone on the planet – questions about future healthcare needs and questions about building a responsive, innovative, global business to meet them – as well as questions about their own personal and professional growth.