Shreeya Patel at CK Regulatory is recruiting a Senior Regulatory Manager EU to join a global speciality pharmaceutical company in the South East on a permanent basis.
The job:
As the Senior Regulatory Manager EU you will be provided with an opportunity to gain experience across a range of submission types and strategies so this role would suit someone seeking to add to their current EU submission experience.
Responsibilities:
As Senior Regulatory Manager EU you will be responsible for the definition of regulatory strategy and subsequent implementation, in the EU and EEA regions. As Senior Regulatory Manager EU you will provide appropriate EU regulatory input to project teams to ensure planned drug development activities comply with EU guidelines and, in cases where they do not, you will provide a critical analysis of the risks and issues. As Senior Regulatory Manager EU you will define EU filing strategy (CP, MRP, DCP) identifying risks and issues. You will also ensure effective implementation of the filing plan, publishing and archiving of documents.
Qualifications:
As Senior Regulatory Manager EU you will be planning and implementing regulatory activities in support of lifecycle management. This role requires extensive experience in leading and running EU submissions in development, as well as scientific depth and the strong ability to influence. Someone who has recently held a position with autonomy would be preferable.
How to apply:
For further information about Senior Regulatory Manager EU role or to apply for the position please call Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk. Please quote reference CL24680 in all correspondence.
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