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A Regulatory Affairs Consultant with specialist Clinical experience is require for a 12 month contract with a global biotechnology company.
The Regulatory Consultant will join a busy department and will be responsible for preparing and filing necessary regulatory documents for Clinical Trial Applications. The successful candidate will also be responsible for handling interactions with clinical study team and regulatory LOCs/Hubs regarding clinical trials activities. These activities include maintenance activities such as dealing with amendments/notifications.
Applicants must have prior experience of authoring IMPDs and liaising with senior team members to gain team endorsement of the various sections of the IMPD. You will be a proven multi-tasker, with the ability to manage several multi national clinical trials keeping each study on its time goals. You will also be able to contribute to protocol amendment preparation discussions (impact assessment of scope of protocol amendment on CTA approvals). You will have responsibility to create and manage regulatory clinical trials activity trackers and will prepare/communicate status reports based on these trackers to stakeholders. It is important that you are comfortable communicating with senior management and external stakeholders; excellent communication skills are essential for this role as is an ability to work with global contacts.
Additional duties will include reviewing and approving clinical trial labels, participating and contributing to clinical study team meetings and attending regulatory focus meetings.
Experience of Scientific Advice, Protocol Development, Paediatric Investigation Plans or end of Phase II meetings would be advantageous.
For additional information and a confidential discussion, please contact Trish Kelly on 020 3465 0045.
Please click the apply now button and search for reference number: 1627232