Managed Services Specialist

Responsibilities File regulatory submissions (from the company's portfolios) to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels. Update required the company's internal systems and databases with regulatory affairs information, as per their SOP's such as Vault RIM. Communicate and work with the company's local (eg, Canada brand team) and global stakeholders, according to their SOPs. Prepare ASMF (Active Substance Master File) regulatory submissions to Health Canada. Interact directly with Health Canada, and to address questions on filed submissions to ensure approval. Create detailed Yearly Biologic Product Reports (YBPR) by gathering data from the CPID, following regulatory guidelines and coordinating communication with key stakeholders. Oversee and coordinate the submission of Public Release of Clinical Information (PRCI), ensuring clear communication with internal teams and Health Canada.