Tracy Brown Email and Phone Number

•Screening vaccine product submissions, including new drug submissions, within established time frames to verify conformity with Health Canada’s guidelines, policies and the Food and Drugs Act and Regulations, ensuring they are adequate for scientific review •Leading a multi-directorate working group charged with the revision of a branch level guidance document •Coordination and project management of pre- and post-market submissions to ensure they meet performance target times•Provision of regulatory guidance to industry, and internal stakeholders•Contact Representative for sponsors/reviewers for product and submission related inquiries•Organizing, co-ordinating and facilitating meetings with Industry and internal stakeholders

Temporary/Rotating Acting position + other various acting assignments in this position•Responsible for the direct supervision of scientific staff•Preparing and delivering presentations to industry at association conferences •Preparing and delivering presentations to and debriefing of upper management •Providing significant oversight of pre- and post-market submissions including new drug submissions for vaccines and in participating in team reviews•Workload management, delegation and assessment of work within the Regulatory Affairs Vaccines Unit•Organization and facilitation of meetings with Industry and other stakeholders•Screening vaccine product submissions, including new drug submissions, within established time frames to verify conformity with Health Canada’s guidelines, policies and the Food and Drugs Act and Regulations, ensuring they are adequate for scientific review•Coordination and project management of submissions to ensure they meet performance targets•Providing regulatory guidance to industry and internal clients•Responsible for providing regulatory advice to industry regarding the filing of biologic submissions•Experienced in preparing regulatory correspondence•Leading and participating on working groups as a Division or Directorate representative

•Development and Revision of guidance documents in line with Good Guidance Practices•Development and posting of Notices regarding eCTD submissions to the Health Canada Website•Lead a multi-directorate working group charged with the revision of the Health Canada guidance documents: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format and •Preparing and delivering presentations to Industry at association conferences •Preparing and delivering presentations to and debriefing of upper management •Lead and participate on working groups as a Division or Directorate representative•Supervision of staff•Workload management, delegation and assessment of work within the Policy and Training Team