Job Description

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.