An excellent opportunity has arisen for a Senior Regulatory Executive to join a leading generics company based in the North of Wales.
As a Senior Regulatory Affairs Executive you will be a key member of the team, supporting new product development and existing licence maintenance, proposing improvements to internal systems, representing the department at internal and external meetings and providing advice on regulatory requirements. You will prepare, submit and manage to approval new marketing authorisation applications, variations and renewals in the UK, Ireland and other markets, as required. You will also review artwork and production documentation to ensure compliance.
-You will have a degree or equivalent in life sciences, good technical knowledge of European Regulatory Affairs particularly in CMC
-Experience handling new marketing authorisation applications and post-licensing activities.
-You will be self-motivated, have an exceptional eye for detail and excellent problem-solving and decision-making capabilities.
-You will have the ability to multi-task and to plan and prioritise your workload to meet expected deadlines.
-You will be able to communicate effectively with people at all levels within and external to the organisation and to present the Company's interests in a professional and authoritative manner.
For further details please contact Tim Barratt on +44(0)1727 817 626 or email firstname.lastname@example.org