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At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Global Regulatory Manager (GRM) to join our A-team (hybrid*/remote). 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, Allucent's Senior Leadership team, Business Development, Auditors and Inspectors.
In this role your key tasks will include{{:}
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• Contributes to the KOM if required to cover aspects related to RA/IEC/IRB submission and approval
• Develop Regulatory and Ethics Submission Plan ( ...