We are currently recruiting for an exciting opportunity for a
Regulatory Affairs Technical Lead
to join our Quality team. You will be responsible for the day-to-day provision of medicinal product regulatory licensing activities for Fresenius Kabi in the UK and Ireland. The role is full-time, Monday - Friday and is based at our Head Office in Runcorn, Cheshire. Fresenius Kabi is a global healthcare company that specialises in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company's products and services are used to help care for critically and chronically ill patients. Our product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Responsibilities:
Compile, submit and monitor regulatory submissions to gain approval to market products and conduct clinical trials. Assess provided supporting dossier documentation to ensure adequacy and accuracy for submission. Maintain effective communication between the company and the regulatory authorities during assessment of applications in order to obtain prompt and effective approval. Assess licensed product labelling to ensure compliance with legal and corporate requirements. Maintain effective communication between corporate and regional regulatory colleagues to obtain necessary information/data for regulatory submissions. Review promotional material against the current ABPI Code of Practice, relevant regulations and other applicable guidance. Carry out change control regulatory assessments and regulatory approvals within QMS. Support the business as SME for medicinal product regulatory queries and projects. Provide a professional, responsive and efficient service. Undertake other reasonable duties as assigned by the Head of Regulatory Affairs, UK and Ireland. Minimum Requirements:
Must possess a scientific degree or an equivalent. Must have prior experience in a Regulatory Affairs department. Must possess excellent communication and interpersonal skills. Previous experience of line management preferable. Good working knowledge of Microsoft Office and IT systems. Benefits:
Contributory Pension Scheme (rises with service). Role specific tailored training and development plan. Life Insurance (4 x salary, death in service). 25 days holiday (rises to 27 after 5 years service) and ability to buy/sell holidays. Maternity, Paternity and Adoption Leave. Professional fees paid. Bike to work scheme. Long Service Awards. Employee Assistance Programme. Free onsite parking and subsidised canteen. Blue Light Card. Company funded family days out.
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Regulatory Affairs Technical Lead
to join our Quality team. You will be responsible for the day-to-day provision of medicinal product regulatory licensing activities for Fresenius Kabi in the UK and Ireland. The role is full-time, Monday - Friday and is based at our Head Office in Runcorn, Cheshire. Fresenius Kabi is a global healthcare company that specialises in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company's products and services are used to help care for critically and chronically ill patients. Our product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Responsibilities:
Compile, submit and monitor regulatory submissions to gain approval to market products and conduct clinical trials. Assess provided supporting dossier documentation to ensure adequacy and accuracy for submission. Maintain effective communication between the company and the regulatory authorities during assessment of applications in order to obtain prompt and effective approval. Assess licensed product labelling to ensure compliance with legal and corporate requirements. Maintain effective communication between corporate and regional regulatory colleagues to obtain necessary information/data for regulatory submissions. Review promotional material against the current ABPI Code of Practice, relevant regulations and other applicable guidance. Carry out change control regulatory assessments and regulatory approvals within QMS. Support the business as SME for medicinal product regulatory queries and projects. Provide a professional, responsive and efficient service. Undertake other reasonable duties as assigned by the Head of Regulatory Affairs, UK and Ireland. Minimum Requirements:
Must possess a scientific degree or an equivalent. Must have prior experience in a Regulatory Affairs department. Must possess excellent communication and interpersonal skills. Previous experience of line management preferable. Good working knowledge of Microsoft Office and IT systems. Benefits:
Contributory Pension Scheme (rises with service). Role specific tailored training and development plan. Life Insurance (4 x salary, death in service). 25 days holiday (rises to 27 after 5 years service) and ability to buy/sell holidays. Maternity, Paternity and Adoption Leave. Professional fees paid. Bike to work scheme. Long Service Awards. Employee Assistance Programme. Free onsite parking and subsidised canteen. Blue Light Card. Company funded family days out.
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