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The RS (Resourcing Solutions) department of Chiltern International acts in a similar way to that of a staffing solutions provider. The department is currently seeking a Manager, Regulatory Manager, UK and Ireland, to work for our client, a global Pharma company. This is a permanent headcount position.
Job Primary Functions
This role provides real opportunity to gain experience and exposure to working within the EU Lifecycle team, as they will get the opportunity to work on EU projects. The individual will get the opportunity to work with in-country teams as well as work cross functionally with the commercial teams. They will be given the opportunity to sit on the UK Management team (subject to experience levels) as well as interact with Global CMC and Global Labeling. This is a real chance for someone to step into a fully responsible and autonomous role with the opportunity for wide and broad exposure within the UK organisation and the wider EU and Global teams. There is a good opportunity for this role to move into a more EU focused role in the future – or perhaps into another area of Reg Affairs (Development team for example) – in due course.
- Supports the implementation of regulatory operational activities in the UK/Ireland, and provides regulatory support to the registration and post-licensing of EU medicinal products in the UK/Ireland region.
- Is responsible for the maintenance of regulatory packaging, tracking systems and regulatory knowledge databases for the UK/Ireland.
- Reviews and approves product-related packaging and other materials, as required and in accordance with company metrics/agency deadlines e.g. Braille, Patient Information Leaflet User Testing, etc., ensuring regulatory compliance.
- Liaises with EU RA, the Packaging Co-ordination group (PCEAM) and logistics to ensure that any labelling changes are planned and implemented in line with company and agency expectations.
- Plans and implements regulatory activities in support of lifecycle management (renewals and variations) in the UK/Ireland. Establishes relationships with EU regulatory teams thereby ensuring local RA activities are in line with global and regional business priorities.
- Plans and implements regulatory activities in support of lifecycle management (renewals) and CMC maintenance in the region. Ensures effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.
You will need the following experience;
- Must have had direct UK & Ireland submissions experience in renewals and variations Ideally have small/medium Pharma background
- Good direct interaction with UK and Ireland Health Authorises Experience of artwork implementation
- Good solid understanding of UK and Ireland regulations
- Worked cross functionally with Commercial Proven ability to demonstrate strong problem solving skills
A full job description is available
pharma, healthcare, UK and Ireland, office based, Regulatory, Regs, Regulatory affairs, Manager, Regulatory Affairs, EU, centralised procedure, clinical trials, senior regulatory associate, Marlow, Buckinghamshire, Bucks, south east, biotech, regulatory development, permanent, pharmaceutical.