Regulatory Affairs Consultant- Consumer Healthcare

AMS Contingent Team ,
Reading, Berkshire
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Overview

Alexander Mann Solutions (AMS) is the world's leading provider of Talent Acquisition and Management Services. We deliver award-winning solutions to over 65 outsourcing clients and consulting services to hundreds more. Our Contingent Workforce Solutions (CWS) service acts as an extension of our clients' recruitment team and provides professional interim and temporary resources. Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference on patients' daily life, wherever they live and enable them to enjoy a healthier life. On behalf of this organisation, AMS are looking for a Regulatory Affairs Consultant for a 6-12 month contract based in Reading. Purpose of the Role: Leads the coordination, preparation, submission and the follow up registration appli-cations to the UK and /or Irish regulatory authorities, expeditiously and to high standards, to ensure that marketing authorizations are obtained and maintained in line with the company's plans and goals. Supports the launch of new products and life cycle management of the existing portfolio. Assist and provide support in the preparation, distribution and follow up of registration documentation required in the EU (particularly UK and Ireland). As a Regulatory Affairs Consultant you will be responsible for: Ensures that all data supplied to the regulatory authorities are of the highest quality possible in terms of both content and presentation, whilst meeting agreed deadlines. Works proactively with members of the Global Business Units and other Global functions to ensure project needs are met compliantly within agreed timelines Contributes to the effective running of departmental and cross functional project teams Assists in supervision and training of regulatory staff as required What we require from the candidate: Degree or Professional qualification in Science, preferably Life Science or proven relevant experience within the regulatory environment. Minimum 3 years experience in the CHC pharmaceutical industry or a related field desirable Proven familiarity with the pharmaceutical research and development process with ability to critically review and integrate scientific information from a variety of disciplines. Administratively well organised, demonstrating attention to detail, strong written and oral communication skills and be able to manage multiple priorities. Thorough knowledge of regulatory requirements (though training provided both on the job and externally) IR35 Status: This role has been assessed as inside of IR35. If you are interested in applying for this position and meet the criteria outlined above, please click the link to apply and we will contact you with an update in due course. Applications close on 31st March 20 Alexander Mann Solutions, a Recruitment Process Outsourcing Company, may in the delivery of some of its services be deemed to operate as an Employment Agency or an Employment Business

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