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

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. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 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.