Compliance

• Preparing, reviewing and submitting CTAs for small molecules, biologics and natural health products to Health Canada's Directorates (TPD, BGTD, NHPD)
• Company contact and regulatory liaison with Health Canada
• Analyses the information provided by the sponsor and prepares a complete file showing the relevant information to the regulatory body
• Oversight and/or preparation of all responses to all Health Canada clarifications requests
• Performs the needed follow-ups to insure that the regulatory requirements needed to start a study are met
• Maintenance of submission (CTA-A, notification, cancellation)
• Responsible for assigned study submissions to the IRB, including interactions, answering to clarifications when needed, and ensuring IRB requirements are met prior to protocol implementation
• Preparing and submitting exemption application for controlled substances
• Maintains a database for regulatory submissions and related questions
• Responsible for submission/maintenance of annual clinical documents to IRB
• May provide regulatory support for drugs, biological products, medical devices, 505b2 program, IND requirements and regulatory documentation (such as CTD/NeeS/eCTD format requirements)
• May participates to drug development files to be submitted to the regulatory bodies (ex.: pre-IND, IND, pre-CTA)
• May communicates with Health Canada to insure the feasibility and filling requirements of clinic trials requests on the regulatory level
• Maintain current awareness on regulatory guidelines (such as Health Canada's TPD, NHPD, and BGTD, FDA) and ensure processes are adjusted as necessary
• Undertake continuous learning and development on regulations through self-training, workshops and conferences
• Present details of workshops/courses attended or new knowledge acquired
• Prioritize own work and manage project schedule to meet delivery deadlines
• Represents Algorithme Pharma in scientific meetings/exhibitions or business meetings

Regulatory Affairs Associate

Director, Privacy Compliance

Regulatory Compliance Officer – Clinical Trials

Manager, Regulatory Operations

Regulatory Intelligence Intern

Regional Compliance Officer