Are you ready to play a critical role in bringing life-changing biologics and vaccines to patients worldwide? We’re looking for a CMC Strategy Senior / Regulatory Affairs Consultant who thrives in a dynamic, team-oriented environment and is passionate about shaping global regulatory strategies. In this role, you’ll work within a dedicated client program, partnering closely with a leading organization to drive high-impact submissions and lifecycle management activities across both development and commercial products.

Lead and contribute to global CMC regulatory strategies for commercial biologics and vaccine products Support and drive post-approval regulatory activities, including variations, supplements, manufacturing changes, CMC changes, lifecycle maintenance, and health authority commitments Author and review high-quality CMC documentation (Modules 1-3) for global submissions Perform CMC dossier gap analyses and provide clear, strategic recommendations Lead and support global submissions (US, EU, and international markets) from planning through execution Partner cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Technical Operations, and client stakeholders Assess regulatory impact of product, process, manufacturing, analytical, and control strategy changes Act as a key contributor within a dedicated client team, building strong, trusted relationships Ensure submissions meet global regulatory expectations with precision, quality,



and compliance 5+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant role; 7+ years for a Senior Regulatory Affairs Consultant role ~ Demonstrated post-approval CMC regulatory experience supporting commercial biologics and/or vaccines (required) ~ Site transfers ~ Strong knowledge of global regulatory requirements, including FDA, EMA, and international markets Experience performing CMC dossier assessments and gap analyses Experience supporting both clinical development and commercial lifecycle management activities Experience with Veeva Vault RIM, eCTD publishing, and regulatory information management systems Advanced scientific degree (MS, PhD, PharmD, or equivalent) Build deeper relationships and drive long-term impact through a strategic partnership rather than project-based work. Gain experience across US, EU, and international regulatory landscapes while supporting global product portfolios. Be recognized as a strategic regulatory partner while expanding your expertise in biologics, vaccines, and post-approval CMC strategy.

If you have experience supporting approved biologic and/or vaccine products through post-approval regulatory submissions and lifecycle management activities and are looking for a role where your expertise is valued, your voice is heard, and your work truly matters, we'd love to hear from you. #

📌 Senior Regulatory Affairs Consultant - (Post Approval CMC Authoring - Vaccines or Biologics) (Winnipeg)
🏢 Parexel International
📍 Winnipeg