A new opportunity has arisen to join a global Pharmaceutical organisation, who is a true leader in its field, to play a role in the development and implementation of regulatory strategy across Europe. In an ever changing Regulatory environment, this key position plays a significant role in the definition of EU filing strategy whilst making recommendations to Global Regulatory and Development teams.
As a member of the European Regulatory Affairs group, you will be expected to provide regulatory advice and intelligence to assist the planning of significant commercial projects. As such a clear understanding of Regulatory Agencies and Health Authority requirements, as well as an ongoing familiarity of such requirements is critical. With this, you will be a key individual involved in ensuring ongoing and planned development activities comply with EU guidelines.
There is also a responsibility for supporting current commercial activities too, and you will be involved in the planning and implementation of activities which support renewals and CMC maintenance in the region. This will include ownership of projects where there is no formal project team, as well as management of marketed product labelling to ensure ongoing compliance with regional Regulatory requirements, through to the implementation of CMC changes in line with agreed global CMC plans.
As a critical member of the regional group, you will provide input into budgets and forecasts, as well as support other colleagues and may be required to mentor more junior members of staff if required.
To be successful in this role, you should have an excellent understanding of EU Regulatory procedures and processes including CP / DCP / MRP. Also, you will have a strong knowledge of Regulatory involvement across the drug development and commercialisation lifecycle including marketing, CMC, and labelling. You will be a Graduate in a Life Sciences subject, with ideally a post-graduate level scientific or business qualification with prior relevant experience within a Regulatory Affairs group, and have demonstrated exceptional planning, organisation, analytical and collaboration skills. Being able to think strategically and the ability to communicate and negotiate effectively whilst influencing others are all important skills required to be successful in this role.
In return, you will be rewarded with an outstanding package of benefits which you would expect from a leading Pharmaceutical company, which ranges far further than just salary and holiday. If you are interested in finding out more about this or other opportunities please apply now or contact david.jolley@quanticate.com.