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

Accountabilities

• • Lead and contribute to global CMC regulatory strategies for commercial biologics and vaccine products, with a focus on post-approval lifecycle management.
  • Drive and support regulatory activities including variations, supplements, manufacturing and process changes, analytical updates, site transfers, specification changes, and health authority commitments.
  • Author and review high-quality CMC documentation across regulatory submission Modules 1–3, ensuring accuracy, consistency, and compliance with applicable requirements.
  • Conduct CMC dossier assessments and gap analyses, translating findings into clear and actionable regulatory recommendations.
  • Support global submissions across the United States, European Union, and international markets from planning and strategy through execution.
  • Assess the regulatory impact of changes to products, manufacturing processes, analytical methods, specifications, and control strategies.
  • Collaborate closely with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Technical Operations, and other cross-functional stakeholders.
  • Act as a trusted regulatory partner within a dedicated client team, building strong relationships and providing strategic guidance.
  • Ensure regulatory submissions and lifecycle activities meet global expectations for quality, precision, consistency, and compliance.

  Requirements

  • 7+ years of relevant experience in CMC Regulatory Affairs or CMC Strategy for a Senior Regulatory Affairs Consultant position.
  • Demonstrated post-approval CMC regulatory experience supporting commercial biologics and/or vaccine products.
  • Hands-on experience managing lifecycle maintenance activities for approved biologic or vaccine products, including post-approval supplements, variations, manufacturing changes, process changes, analytical method updates, site transfers, specification changes, health authority commitments, or labeling-related CMC changes.
  • Strong understanding of global regulatory requirements and submission expectations, particularly those of the FDA, EMA, and international health authorities.
  • Proven experience contributing to global regulatory submission strategy and execution.
  • Strong expertise in authoring and reviewing CMC Modules and preparing high-quality regulatory documentation.
  • Experience conducting CMC dossier assessments and identifying regulatory gaps, risks, and required actions.
  • Strong communication, collaboration, and stakeholder management skills, with the ability to work directly with clients and cross-functional teams in a matrixed environment.
  • Experience supporting both clinical development and commercial lifecycle management activities is an advantage.
  • Experience with vaccines, biologics, monoclonal antibodies, recombinant proteins, gene therapies, or other advanced biologic modalities is preferred.
  • Familiarity with Veeva Vault RIM, eCTD publishing, and regulatory information management systems is a plus.
  • An advanced scientific degree such as an MS, PhD, PharmD, or equivalent is preferred.

  Benefits

  • Full-time opportunity based remotely in Canada.
  • Dedicated client partnership offering deeper relationships and the opportunity to drive long-term regulatory impact.
  • Meaningful work supporting the development and lifecycle management of biologics and vaccines that can improve patient outcomes globally.
  • Exposure to regulatory strategies and submission requirements across the US, EU, and international markets.
  • Opportunity to expand expertise in biologics, vaccines, and post-approval CMC strategy.
  • High level of professional ownership and visibility as a strategic regulatory partner.
  • Collaborative environment with close interaction across regulatory, quality, manufacturing, technical, and client teams.
  • Opportunity to contribute to complex global product portfolios and develop long-term regulatory expertise.