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CK Group
,
Leeds, West Yorkshire
Senior Regulatory Affairs Specialist
Overview
CK Group are recruiting for a Senior Regulatory Affairs Specialist to join a company in the Pharmaceutical industry at their site based in Leeds on a 12 month contract basis, with an hourly rate of £55 per hour Ltd. The Company: Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies - the largest diversified healthcare group in the world with over 100 years of scientific heritage. They employ approximately 500 people in the UK and Ireland. They are committed to delivering great medicines and have introduced a range of innovative treatments that can make an important difference to the lives of patients with serious health conditions such as schizophrenia, hepatitis C, multiple myeloma, HIV/AIDS and diabetes. The Location: Leeds is well connected and one of the principal hubs of the northern motorway network. Additionally, there is an urban motorway network; the radial M621 takes traffic into central Leeds from the M62 and M1. The Role: - Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities. - Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. - Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. - Define data and information needed for regulatory approvals. - Develop labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations. Your Background: To be considered for the role you should have the following skills, knowledge and experience: - BS with minimum 6 years of experience or equivalent. - Practical experience with the preparation and submissions for Class II and III medical devices (EU and USA). - Substantial experience of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred. - Knowledge of Additive manufacturing technology and associated regulations ( Software), advantageous. - The client is looking for someone with 510K submission experience. For more information or to apply for this Senior Regulatory Affairs Specialist position, please contact CK Group, quoting job ref 48021. It is essential that applicants hold entitlement to work in the UK.