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Regulatory Specialist ll


Joblift


Location

Nouvelle Aquitaine | France


Job description

Global Regulatory Manager (SSU) - Global CRO - Home Based - Europe Wide Incredibly excited to be partnering with my client to support their hiring into this new Global Regulatory Manager role within their European Structure. We are looking for a Senior SSU Regulatory Specialist with a strong background of developing and executing Regulatory Submissions Strategy for Global Studies. The Global Regulatory Manager is responsible for managing regulatory activities, developing and implementing strategies for timely (regulatory) approvals, ensuring timely preparation and submission of local, regional and global submissions to RAs/IECs/IRBs, ensuring the quality, content and format of regulatory submissions; serving as a direct point of contact for regulatory questions raised by the Sponsor, client Senior Leadership team, Business Development, Auditors and Inspectors. The GRA is a member of the Study Start-Up & Site Intelligence unit. We are representing a phenomenal mid-sized CRO who are currently performance extraordinarily well which has seen their sponsor partnerships grow at an accelerated rate, hence the new hires into their Start Up Teams. This role represents an incredible opportunity for you to play a pivotal role in developing new process to accelerate Regulatory and Trial Start Up Approval and make a significant impact to the success of this business.


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