Senior Regulatory Affairs Consultant – Post Approval CMC Authoring, Vaccines or Biologics

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead and shape global CMC regulatory strategies for commercial biologics and vaccine products.

• Support and drive regulatory activities post-approval, encompassing variations, supplements, manufacturing alterations, CMC modifications, lifecycle management, and commitments to health authorities.

• Author and review CMC documentation in Modules 1–3 for worldwide submissions.

• Conduct CMC dossier gap analyses and deliver strategic recommendations.

• Guide and support global submissions from the planning phase through to execution.

• Collaborate cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Technical Operations, and client stakeholders.

• Evaluate the regulatory implications of changes in product, process, manufacturing, analytical, and control strategies.

• Contribute as a vital member of a dedicated client team and cultivate trusted relationships.

• Ensure that submissions align with global regulatory expectations, maintaining precision, quality, and compliance.

⛳️ Requirements

• Over 5 years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant position; over 7 years for a Senior Regulatory Affairs Consultant position.

• Proven post-approval CMC regulatory experience supporting commercial biologics and/or vaccines.

• Practical experience managing lifecycle maintenance activities for approved biologic and/or vaccine products.

• Familiarity with post-approval supplements, variations, manufacturing modifications, process alterations, analytical method updates, site transfers, specification changes, health authority commitments, or labeling-related CMC changes.

• Comprehensive knowledge of global regulatory standards, including FDA, EMA, and international markets.

• Established experience in supporting global submission strategies and execution.

• Proficiency in authoring and reviewing CMC Modules.

• Experience in conducting CMC dossier evaluations and gap analyses.

• Strong communication, collaboration, and stakeholder management capabilities.

• Ability to work directly with clients and cross-functional teams within a highly matrixed environment.

• Preferred: experience in supporting clinical development and commercial lifecycle management activities.

• Preferred: experience with vaccines, biologics, monoclonal antibodies, recombinant proteins, gene therapies, or other advanced biologic modalities.

• Preferred: experience with Veeva Vault RIM, eCTD publishing, and regulatory information management systems.

• Preferred: advanced scientific degree (MS, PhD, PharmD, or equivalent).

🏝️ Benefits

• Dedicated client partnership and strategic collaboration opportunities.

• Engaging work that contributes to innovative biologics and vaccines enhancing patient lives globally.

• Exposure to global regulatory landscapes across the US, EU, and other international markets.

• Opportunities for growth and influence through an expanding knowledge base in biologics, vaccines, and post-approval CMC strategy.