Manager, Regulatory Affairs

**Location:** Remote (Greater Toronto Area / GTA) [and adjacent communities] with periodic in-person meetings **Job Type:** Full-time **Industry:** Regulatory Affairs & Quality Consulting (Pharmaceuticals, Nutraceuticals, Foods) **About the Role** Quality Smart Solutions Inc. is a science and compliance consulting firm globally serving consumer health product companies in Natural Health Products, Dietary Supplements, Over-The-Counter DIN products, Foods and Cosmetics regulatory and quality areas. Our fast, cost effective, solutions-oriented approach has ensured client satisfaction and has established Quality Smart Solutions as the preferred partner in science and compliance having served over 600 global clients, licensing over 5000 products and sites and completed over 15,000 projects. Are you a strategic regulatory leader looking to drive compliance excellence and operational growth? We are seeking an experienced and visionary **Manager, Regulatory Affairs** to lead our consulting practice and serve as our ultimate technical authority. In this high-impact leadership role, you will oversee department architecture, mentor a multidisciplinary consulting team, and serve as the **Most Responsible Person (MRP)** for complex regulatory strategies, agency escalations, and health authority submissions. This position operates on a **hybrid-remote model from the Greater Toronto Area (GTA) [and adjacent communities]**, blending remote autonomy with periodic in-person meetings for strategic alignment. **Key Responsibilities** **1. Regulatory Strategy & Technical Authority** * Serve as the firm’s ultimate technical signatory and Most Responsible Person (MRP). * Monitor real-time regulatory updates across governing bodies; conduct gap analyses on evolving acts, regulations, guidance documents, and monographs. * Provide authoritative oversight for high-risk submissions, dossiers, labelling requirements, and novel pathway interpretations for Health Canada (and US FDA). * Lead responses to critical regulatory actions (e.g., Health Canada Stop-Sale orders, FDA observations, product recalls) and resolve complex legislative ambiguities. * Translate evolving regulatory requirements into actionable business intelligence and conduct internal "Regulatory Briefings" for staff. **2. Strategic Leadership** * Design and optimize consulting team structures to ensure scalability, quality execution, and healthy profit margins. * Translate executive goals into actionable operational plans, service line expansions, and headcount/subcontractor roadmaps. * Identify, escalate, and mediate contractual regulatory exposure and practice liability. * Champion change management, adopting new regulatory service lines and tech tools to drive consulting efficiency. **3. People Management & Human Capital** * Own the hiring roadmap, capacity planning, contractor usage, and recruitment strategy. * Mentor and develop consulting staff; define the company-wide *Technical Competency