Regulatory Affairs Coordinator

Red Recruitment Solutions ,
Shrewsbury, Shropshire

Overview

Job Description

An exciting opportunity has arisen to join our client, a global organisation specialising in pharmaceutical products in a B2B environment. This interesting and varied role will involve assisting in the registration of Veterinary medicinal products in the EU and export markets. Main Duties / Responsibilities: * Preparing registration applications according to EU and national requirements. * Formatting the marketing authorisation applications to meet the current requirements for electronic submissions. * Prepare and submit manufacturing variations (amendments); renewal applications and annual minor changes and stability reports for existing Marketing Authorisations. * Ensuring the maintenance of existing Marketing Authorisations in all countries where they are registered, contact with Regulatory authorities to progress any outstanding issues. * Liaising with our artwork team to help co-ordinate the production of new packaging in relation to regulatory legislation and packaging guidelines. To be considered for this vacancy you will have: * Experience of working as part of a team and on own initiative. * Experience of responding to queries and problem solving. * Be relationship focused and have experience in project management. * Setting up and maintaining manual and electronic filing systems. * Practical experience of working in a busy office environment. * Be educated to degree level or equivalent. You must have previous regulatory experience. It is also essential that you have a science related degree to be considered for this position. This position is a full time, permanent role. Offering a highly attractive salary of between 25,000 and 35,000 per year DOE. As our client is located in a rural location, on the outskirts of Shrewsbury, own transport is required. If you are interested in applying for this role please send your CV to Rob at Red Recruitment today! *We aim to reply to all applications within 48 hours. By applying for this position you give your consent for us to keep your CV for up to 3 months. In the event that you have been unsuccessful for this position, we will retain your details should anything else suitable become available. Please request in writing should you not wish us to retain your details for this purpose. Your details will not be shared with any third party without your express permission. Responsibilities: An exciting opportunity has arisen to join our client, a global organisation specialising in pharmaceutical products in a B2B environment. This interesting and varied role will involve assisting in the registration of Veterinary medicinal products in the EU and export markets. Main Duties / Responsibilities: Preparing registration applications according to EU and national requirements. Formatting the marketing authorisation applications to meet the current requirements for electronic submissions. Prepare and submit manufacturing variations (amendments); renewal applications and annual minor changes and stability reports for existing Marketing Authorisations. Ensuring the maintenance of existing Marketing Authorisations in all countries where they are registered, contact with Regulatory authorities to progress any outstanding issues. Liaising with our artwork team to help co-ordinate the production of new packaging in relation to regulatory legislation and packaging guidelines. To be considered for this vacancy you will have: Experience of working as part of a team and on own initiative. Experience of responding to queries and problem solving. Be relationship focused and have experience in project management. Setting up and maintaining manual and electronic filing systems. Practical experience of working in a busy office environment. Be educated to degree level or equivalent. You must have previous regulatory experience. It is also essential that you have a science related degree to be considered for this position. This position is a full time, permanent role. Offering a highly attractive salary of between 25,000 and 35,000 per year DOE. As our client is located in a rural location, on the outskirts of Shrewsbury, own transport is required. If you are interested in applying for this role please send your CV to Rob at Red Recruitment today! *We aim to reply to all applications within 48 hours. By applying for this position you give your consent for us to keep your CV for up to 3 months. In the event that you have been unsuccessful for this position, we will retain your details should anything else suitable become available. Please request in writing should you not wish us to retain your details for this purpose. Your details will not be shared with any third party without your express permission.