Specialist, Regulatory Affairs

Specialist, Regulatory Affairs

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Summary

As a Specialist, Regulatory Affairs, you will support the Associate Director and Manager of Regulatory Affairs and oversee submission operations across all therapy areas. You will manage a portfolio of projects for approved Ipsen products and the lifecycle of the pipeline in Canada, ensuring timely and compliant regulatory filings to Health Canada. The role maintains strong relationships with Health Canada and internal/external stakeholders, and provides operational support for special projects.

Main Responsibilities & Technical Competencies

• Assist in the preparation and compilation of regulatory submissions (e.g., NDSs, SNDSs, CTAs, Level III, NCs).
• Support the preparation and review of responses to Health Canada questions and queries in a timely manner.
• Participate and assist in Health Canada meetings ...