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Science & Technology Recruitment
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London, Greater London
Senior Regulatory Officer
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Job Type: Full-time |
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Overview
This is an opportunity to work for a well establish company in the London area. This position involves supporting the development of a pipeline of generic pharmaceuticals Responsibilities Liaise with the QA department and the manufacturing and development sites to get the required data to populate the dossier Provide strategic regulatory advice on development projects Prepare scientific advice requests and attend meetings with MHRA and other national competent authorities Write Module 1 and Module 3, Prepare Module 2, Prepare MAA (dossier) Liaise with clinical consultants to prepare the non-CMC parts of the dossier Prepare associated regulatory submissions Manage regulatory procedures at both EU and UK national level from application through to approval Qualification and experience Successful candidate will have minimum BSc in Life Sciences, Chemistry or related discipline with 5 years’ experience in Regulatory affairs Good Knowledge of Clinical development activities would be desirable Experience with generic drug development programmes Pre and post marketing experience Strong communication skills (both written and orally) Attention to detail Efficient and timeline/target orientated Ability to work both independently and within a team Ability to work in a cross-cultural environment, experience working with India and China an advantage To apply for this position, candidates must be eligible to live and work in the UK