Regulatory Affairs Manager

2 weeks ago

hampshire, United Kingdom JR United Kingdom Remote Work Freelance Full time

Our client, an independent pharmaceutical company who manufacture and specialising in generics, have an opportunity for an experienced EU/ UK Regulatory team leader to join their team in Hampshire.As Regulatory Affairs manager, you will:Leading a small team, handling the regulatory activity across a large portfolio of medicine and medical device/ combination productsWorking with EU, UK, and RoW regulatory bodies; as the subject matter expert for Medicines; Medical Devices and related ISO activities (including ISO13485 and ISO14971); Controlled Drugs; Nutritional Products; In Vitro Diagnostic Devices; Biocidal ProductsReview and support for submission of new product dossiers and technical files – both own development, in-licensed and out-licensed and all aspects of regulatory lifecycle maintenance for existing productsAuthor technical documentation, including EU eCTD dossier sections, technical file documents and product artwork, for alignment with applicable regulations and guidance and assessing suitability for submission where appropriate.Regulatory Strategy and Scientific WritingFinial signatory on artwork and labelling materialTo be considered for the role of Regulatory Affairs Manager, you will: Minimum of 5 years of Regulatory Affairs experience in a relevant pharma environmentEducated to degree level in a relevant life science disciplineMust have line management experience - ideally 3 or more direct reportsWorked in a broad role, covering R&D projects and CMC knowledge Must be commercially astute , with regular interactions with regulators and external stakeholdersMust have proven experience with EU and UK regulations for medicinal products/ devicesDue to the nature of the team, this person will be required at the Hampshire office at least 2 times a week. Hybrid working.

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