Regulatory Analyst Job in Hull HU11AA, Yorkshire UK
My client is a leading pharmaceutical manufacturer based in the North East. Due to continued growth they now have an immediate requirement for a Regulatory Analyst to join their team.
In this role you will be responsible for completing comparative analysis reviews in order to ensure conformance between global marketing authorities and company documents and practices. You will collect and summerise information required for gap analysis to be performed, review plant documentation for accuracy and compliance and complete and highlight compliance comparative analysis review between company technical documents and CMC documents registered with Global Boards of Health.
In order to be successful in this role you will have a keen attention to detail with a "right first time" mentality. You must be able to operate in a multi-functional environment and have a working knowledge of cGMP and cGLP.
It is envisaged that the ideal candidate will have a minimum of a Bachelor's degree in a Life Sciences subject coupled with extensive industry experience. CMC experience is highly preferred and you must have knowledge of international guidelines (ICH, WHO) and experience working with international regulatory agencies (FDA, EMA, TGA)