Regulatory Affairs Executive
To compile and submit data packages to Regulatory Authorities in support OF marketing authorisations (new applications, variations, renewals and other maintenance activities) and applications to market products including medicinal products, cosmetics and medical devices in the UK, other EU member states, CIS countries, the Middle East and African nations.
Other activities in support of the company objectives will also be a requirement, including but not limited to, regulatory input to new product development projects, advertising & promotional review and approval, label and leaflet amendments and technical evaluation of product data.
• Compile administrative and scientific documentation for international registration, including Export Certificates, in accordance with the respective defined formats, guidelines, and dispatch to our Agents/Distributors for submission to competent authorities.
• Maintain compliance of the Company's product, Manufacturer's and Wholesale dealers licences, submitting any changes to the authorities in a timely manner
• Compile and maintain documentation necessary to ensure regulatory compliance of cosmetics, general products and medical devices.
• Assess UK, Irish and European advertising and promotional materials for compliance with the appropriate marketing authorisation, the regulations, guidelines and the principles of any codes of practice.
• Draft and obtain internal agreement for texts such as but not limited to Summary of Product Characteristics, package labeling, consumer leaflet texts and the equivalent non-medicinal documents such as Instructions for Use and Technical Files for Medical Devices.
• Participate in, and project manage as appropriate, New Product Development project teams, and other relevant meetings
• Prepare, or review, expert reports for quality, safety and efficacy of products.
• Promote and execute the highest standards of Good Manufacturing Practices to ensure that the facility, documentation, systems and procedures are in a permanent state of inspection readiness.
• Other such duties that may be reasonably required from time to time
• All regulatory submissions are made in a professional, timely and optimally presented manner to maximise the prospects for a successful outcome
• All advertising materials are reviewed such that commercial claims are as impactful as possible without compromising need to comply with relevant regulations
• SmPCs, dossiers, labels and leaflets are permanently in compliance with regulations
• Complete regulatory submissions according to the agreed schedule
Skill and Experience Required:
• Possesses excellent skills in the use of Microsoft tools
• Excellent writing skills
• Ability to argue and seek commercially beneficial outcomes for the context of regulations
• Knowledge of UK medicines legislation
• Knowledge of relevant EU Directives concerning medicines, medical devices and/or cosmetics
• Knowledge of human health and physiology, and principles of pharamcology
• Experience in a regulated environment, preferably in healthcare, pharmaceuticals, medical devices or other sector in which legal & scientific affairs form a central function
• Graduate in a life science or other relevant qualification relation to regulatory affairs