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, collaborative 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.This is more than a delivery role. It's an opportunity to become a trusted advisor, influence strategy, and see your work directly contribute to patient outcomes.What You'll DoLead and contribute to global CMC regulatory strategies for commercial biologics and vaccine productsSupport and drive post-approval regulatory activities, including variations, supplements, manufacturing changes, CMC changes, lifecycle maintenance, and health authority commitmentsAuthor and review high-quality CMC documentation (Modules 1-3) for global submissionsPerform CMC dossier gap analyses and provide clear, strategic recommendationsLead and support global submissions (US, EU, and international markets) from planning through executionPartner cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Technical Operations, and client stakeholdersAssess regulatory impact of product, process, manufacturing, analytical, and control strategy changesAct as a key contributor within a dedicated client team, building strong, trusted relationshipsEnsure submissions meet global regulatory expectations with precision, quality,



and complianceWhat You'll BringRequired Qualifications5+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant role; 7+ years for a Senior Regulatory Affairs Consultant roleDemonstrated post-approval CMC regulatory experience supporting commercial biologics and/or vaccines (required)Hands-on experience managing lifecycle maintenance activities for approved biologic and/or vaccine products, including one or more of the following:Post-approval supplementsVariationsManufacturing changesProcess changesAnalytical method updatesSite transfersSpecification changesHealth authority commitmentsLabeling-related CMC changesStrong knowledge of global regulatory requirements, including FDA, EMA, and international marketsProven experience supporting global submission strategy and executionExpertise authoring and reviewing CMC ModulesExperience performing CMC dossier assessments and gap analysesStrong communication, collaboration, and stakeholder management skillsAbility to work directly with clients and cross-functional teams in a highly matrixed environmentPreferred QualificationsExperience supporting both clinical development and commercial lifecycle management activitiesExperience with vaccines, biologics, monoclonal antibodies, recombinant proteins, gene therapies, or other advanced biologic modalitiesExperience with Veeva Vault RIM, eCTD publishing, and regulatory information management systemsAdvanced scientific degree (MS, PhD, PharmD, or equivalent)Why You'll Love This RoleDedicated Client PartnershipBuild deeper relationships and drive long-term impact through a strategic partnership rather than project-based work.Meaningful WorkContribute to creative biologics and vaccines that improve patient lives globally.Global ExposureGain experience across US, EU, and international regulatory landscapes while supporting global product portfolios.Growth & InfluenceBe recognized as a strategic regulatory partner while expanding your expertise in biologics, vaccines, and post-approval CMC strategy.Ready to Make a Difference?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. #J-18808-Ljbffr

📌 Senior Regulatory Affairs Consultant - (Ottawa)
🏢 Parexel International
📍 Ottawa