Lead site monitoring activities, while also supporting a broad range of clinical responsibilities, including process development, in-house operations, and study oversight.
Craft, refine, and elevate SOPs, WIs, and operational tools that empower teams and strengthen quality.
Oversee IRB submissions and maintain a high-quality TMF, ensuring all essential documents are accurate, timely, and inspection-ready.
The Senior Specialist, Regulatory and PV Network is responsible for developing regulatory strategy, driving regulatory and PV deliverables, and serving as a liaison between regulatory and other functional areas, including external partners and clients. They will act as Local Contact Person for Pharmacovigilance, manage projects, provide strategic input, and ensure compliance with regulatory requirements.
Responsible for building and leading cross-functional quality assurance systems across Loyal teams with an emphasis on FDA-CVM regulatory compliance for drug submissions and products. The work will ensure that all aspects of drug development and clinical operations are high quality, and that any deviations from this are investigated and understood. You will report to our VP of Regulatory and QA.
Provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. Coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.