Regulatory Affairs Project Lead

4 weeks ago


Ontario, Canada Brunel GmbH Full time

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.
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