Lead and execute the regulatory strategy for CAR T programs, serving as the primary regulatory representative, guiding activities across preclinical, clinical, and manufacturing stages, partnering with internal teams and external partners. Work cross-functionally with Clinical, CMC, Quality, and Patient Operations to plan and manage regulatory submissions, including INDs, IND amendments, and meeting packages. The ideal candidate brings experience in Regulatory Affairs within a clinical-stage biotech.
Responsible for the delivery of site activation readiness and mitigating any risks. Preparation of Clinical Trial Application Forms and submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to requirements. Interaction with CA/EC for study purposes and handling responses to the CA/EC. Maintenance of project plans, project trackers and regulatory intelligence tools. Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release.
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.
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. This role ensures all aspects of drug development, manufacturing and clinical operations are high quality, and that any deviations from this are investigated and understood. The Quality Compliance Officer is responsible for maintaining and continuously improving the company’s Quality Management System (QMS).
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.
We are seeking an experienced Regulatory Affairs Contractor to support our Human Health Division, specifically focused on medical device regulatory submissions and compliance. This role is ideal for a detail-oriented professional with a strong understanding and experience of global regulatory requirements. This role will prepare, review and submit regulatory documentation for medical devices and ensure compliance with FDA, EU IVDR, and other international regulatory requirements.
Seeking a detail-oriented and motivated RA/QA professional to support key regulatory and quality activities within our client's medical device operations. This individual will assist with CAPA management, vendor oversight, documentation control, and other compliance-related tasks. Experience with Software as a Medical Device (SaMD) is a plus.