This role will support in the development, commercialisation and lifecycle management of inhalation, conventional or transdermal products for customers on a global basis. This will include membership of development or commercialisation teams providing regulatory advice on product development and maintenance issues. Preparation of regulatory documentation including IMPDs, Drug Master Files and CTD documents and responsibility for estimation and monitoring of regulatory resource requirements.Knowledge and Skills* Detailed Knowledge of European Regulatory Affairs environment - Guidelines & Legislation* Knowledge of Drug development, pharmaceutical R&D and manufacturing processes* Knowledge of non-EU (US/RoW) Regulatory environment* Deep understanding of pharmaceutical business* Able to communicate effectively orally and in writing, to work as part of cross functional teams and independently* Enthusiastic and determined to achieve set objectives* Possess strong computer skills, good organisational capabilities* Demonstrate flexibility and be able to deliver results accurately within demanding time frames * Able to handle crisis or difficult situations in a professional and positive manner* Able to communicate effectively with colleagues at all levels* Able to coach and mentor other staff* Graduate degree (B.Sc. or similar) in pharmacy or a life science or other scientific-based qualifications plus industry experience and knowledge* Significant regulatory experience within the pharmaceutical industry.
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