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CK Group
,
London, Greater London
Regulatory Lead
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Job Type: Full-time |
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Overview
CK Clinical are recruiting for a Regulatory Lead to join a biopharmaceutical company on a full time permanant basis. Company: A start up biotechnology company with excellent growth, products and a varied role. Location: Oxford or London, UK Salary: Flexible and dependant on experience Responsibilities: - Lead and contribute to the regulatory submission and documentation (INDs, CTAs, MAAs) - Lead and develop the implementation of regulatory strategy - Work cross functionally with clinical and commercial teams - Lead and contribute with scientific advice meetings - Interact with regulatory agencies - Maintain up to date knowledge on international regulatory requirements - Provide regulatory expertise, guidance and leadership Your Background: - Experienced within early clinical development - Extensive experience dealing with EU and US markets - Knowledge of medical device EU regulatory standards, ISO and FDA standards - Comfortable working in a start-up environment with a hands-on mentality - Significant experience interacting with research and development - Experience managing a small team would be an advantage, though not essential Entitlement to work in the UK is essential. For more information, please contact Amy Lloyd on . Please quote reference 47904 in all correspondence.