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Medley Pharma Ltd
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Bootle, Merseyside
Regulatory Affairs Assistant
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Job Type: Full-time |
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Salary: £17,500 per annum |
Overview
Medley Pharma is looking for a Regulatory Affairs Assistant to join our team. Our company is at a very exciting stage with a lot of products recently gained approval, therefore is in a major growth phase. Training pertaining to the job role will be provided. The role involves but isn't limited to: Management of compliance with MHRA legislation and guidelines. Liaising directly with the MHRA and uploading work to the MHRA Portal. Defining project and product regulatory strategy in line with commercial and company strategy, consulting with the Quality department. Representation of regulatory affairs at Quality Meetings, providing information, feedback and strategic advice. Management of the production of paper and electronic regulatory submissions. including applications for marketing authorizations. Working closely with the Quality department and assisting with day-to-day activities. Proven experience and skills needed:. Strong communication skills - oral and written Organizational skills. Strong Microsoft office skills and working knowledge of MHRA Portal . Strong team player with a commitment to customer service and relationship building Pre-requisites: Bachelor's degree or higher equivalent This role will be: 9am-5pm Monday - Friday 20 Holidays (Excluding 8 days Bank holidays) Salary is based on expierience.