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• Developing and implementing global labelling processes for a pharmaceutical company with worldwide product licences.
• Providing regulatory strategy and direction to the business regarding healthcare industry regulatory requirements.
• Overseeing labelling activities worldwide for marketed products and creating and maintaining Company Core Data sheets.
• Providing strategic advice in the creation of target labelling for development products.
• Monitoring consistency between local labelling documents and Company Core Data Sheets, and ensuring exceptions are documented through standard process.
The ideal candidate will have a minimum of a Bachelor's Degree, preferably in a Scientific or Life Sciences Discipline, and significant Regulatory Affairs Labelling experience, including direct experience with CCDS, Core Product Information and local labelling in a range of markets including US and EU. Experience developing, implementing and operating global labelling processes for a pharmaceutical company with worldwide product licences is essential. The successful candidate will be a hands-on leader who has experience in all aspects of regulatory labelling for both developing and establishing products. This is a very senior position within the business, and the successful candidate will be expected to provide expert regulatory knowledge and direction to the business.
This role does not provide job sponsorship or relocation.
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