No recruiters please THE COMPANY We are Regulatory Affairs experts who specialise in the UK and EU pharmaceutical industry and offer a bespoke consultancy service to our clients. Our first priority is to have a positive workplace culture where employees feel respected and valued. To achieve this, we only hire talented, dedicated and passionate individuals who share these same values. We take our work-life balance seriously and offer remote and flexible working along with 6 weeks holiday each year and an attractive Vitality private healthcare plan. By prioritising this, our clients benefit from our energetic and committed team who work hard to make our clients' goals, their goals We continue to grow and are delighted to be recruiting for our next member of the team in the Regulatory Affairs Department. THE ROLE There are two aspects to this role as it is split between working on client projects and company projects: 1) Client projects There are opportunities to utilise and grow your experience by working with our established 'big pharma' clients as well as supporting start-ups. Examples of client work includes: Taking responsibility for a portfolio of our clients’ products, carrying out life cycle management activities Joining our clients’ teams to support their regulatory needs Regulatory strategy and scientific advice meetings Running projects such as MAA submissions, de-branding, change of ownership Representation during internal/external audits or Health Authority inspections 2) Fusion projects We strive for continuous improvement and with this brings activities that the whole team contributes towards, such as: Project management Blog and newsletter writing Hosting webinars Regulatory Intelligence – interpreting changes and communicating these to our community Business development activities such as creating marketing materials Representing Fusion Pharma by attending conferences and networking THE ESSENTIAL EXPERIENCE Life Cycle Management activities within a UK and/or EU Affiliate Authoring, compilation of submissions (e.g. variations, Art 61(3), PSURs, MAAs) Experience with National, MR/DC and Centralised procedures Updates to SmPCs, PILs, labelling, mock ups and prescribing information Update to Regulatory tracking systems such as Documentum Communication with the Health Authorities Regulatory strategy THE ESSENTIAL REQUIREMENTS Life Sciences degree Fluent in written and spoken English with excellent communication skills and attention to detail 2 to 4 years Reg Affairs experience (aligned with essential experience as described above) Proficient in Microsoft Office applications with the ability to learn new electronic systems Proven competency with working autonomously and multi-tasking in a fast-paced environment Committed to representing Fusion Pharma to a high standard, face to face and remotely Role requires an enthusiastic, motivated and driven individual The successful candidate will have a professional work setting for company video calls and a high-speed, reliable internet connection THE BENEFITS Competitive salary Permanent and full time Flexible working hours Remote working 6 weeks holiday Private healthcare Pension Thank you for your interest