SUMMARY OF POSITION
Reporting to the Senior Chief, Regulatory Affairs, the incumbent is responsible for the preparation and collection of tactical data relating to international registration files, as well as the preparation and review of submissions.
• Participate on various multidisciplinary teams, coordinate and produce CTD documentation required to meet regulatory requirements for international market documentation;
• Establish and maintain various scales and regulatory databases;
• Provide required support for European submissions, and prepare license renewal submissions for other regions of the world;
• Communicating with clients and business partners to obtain regulatory information and assess the regulatory impact of change controls on global regulatory records in accordance with applicable local and international laws and procedures;
• Create product profiles and participate in gap analysis activities between approved files and records used in manufacturing;
• Participate in the preparation of periodic pharmacovigilance reports on marketed medicines and submit them to the different European agencies, as well as to customers from other regions of the world according to the pre-established schedule;
• Response to regulatory inquiries from customers and business partners from outside the country, as well as from other services;
• Prepare, maintain and improve the SOPs that affect the International Regulatory Affairs Service;
• Ensure records are kept up to date so that they accurately reflect the manufacturing activities of the plant;
• Learn about registration regulations in Canada and internationally;
• Ensure that all service activities are conducted in compliance with applicable regulations (GMP and Corporate Ethics Policy).
• Bachelor of Science (eg, microbiology, chemistry, biochemistry);
• Minimum of 1 year in the pharmaceutical industry in a position related to regulatory affairs;
• Proficiency in oral and written French and English;
• Knowledge of the regulatory systems and regulations of the pharmaceutical manufacturing sector in Canada, the United States and the European Union is an asset.