Regulatory Affairs Specialist

7 days ago

Central London, United Kingdom Quanta part of QCS Staffing Full time

Regulatory Affairs Specialist - London - 12-Month Contract  Do you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries worldwide? Then this is the next step for you One of our global pharmaceutical clients is currently requiring the expertise of an experienced Regulatory Affairs Specialist.  Responsibilities: Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Develops timelines for submissions under the direction of senior regulatory affairs staff. Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables. Provides regulatory advice to project teams. Organises and maintains reporting schedules for new drug application and investigations new drug applications. Requirements: Minimum B.S. Chemistry, Biology, or related fields Significant experience in Cosmetic Regulatory affairs mainly with promotional material and artwork review/approval at all stages of life cycle management, with demonstrated accountability of managing multiple brands. Well versed with UK ASA, CAP, BCAP Guidance for Advertising, proven record of successful project management of dossiers with ClearCast Strong knowledge and application of the UK & EU Cosmetic Product Regulation Excellent leadership, communication, and organisational skills Attention to detail, effective in written and oral communication Works independently to plan, conduct, and manage regulatory projects to meet department and company objectives Responsible for identifying, implementing and managing key RA Departmental projects and/or strategies based on both short- and long-term RA Department objectives. If this role is of interest to you, please apply now   #LI-KT1

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