Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines or Biologics)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines or Biologics) based in Canada.

This role offers the opportunity to shape global regulatory strategies for commercial biologics and vaccine products.
You will play a key role in post-approval CMC activities, supporting products throughout their lifecycle across major international markets.
The position combines regulatory strategy, technical authoring, dossier assessment, and cross-functional collaboration.
You will work closely with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Technical Operations, and client stakeholders.
Your expertise will help ensure complex submissions meet regulatory expectations while supporting timely product and manufacturing changes.
The role provides significant exposure to FDA, EMA, and international regulatory frameworks and global product portfolios.
You will also build trusted client relationships while contributing to therapies that can make a meaningful difference to patients worldwide.