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 quick, 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 Matrix and conduct performance reviews.
- Set utilization targets and Key Performance Indicators (KPIs) to ensure technical precision and high-margin project delivery.
- Foster a positive, collaborative culture grounded in responsiveness, account ownership, and consulting excellence.

4. Financial Oversight & Client Sponsorship

- Maintain departmental budget accountability—monitoring revenue recognition, operating expenses, and utilization to prevent scope creep and margin erosion.
- Review financial dashboards weekly with the Team Leads to align revenue targets with team capacity.
- Serve as Executive Sponsor for top-tier clients and act as the final escalation point for critical disputes or high-stakes regulatory negotiations.

Qualifications & Skills

Education & Credentials

- Required: University degree in Science, Pharmaceutical Sciences, Quality, Regulatory Affairs, Nutrition, Health Science, or a related field.
- Asset: Graduate degree (M.Sc./Ph.D.) or Post-Graduate Certification in Regulatory Affairs.

Experience

- 5–8+ years of progressive experience in regulatory affairs, food safety, quality assurance, or compliance within the pharmaceutical, nutraceutical, food, or consulting industries.
- Health Canada Expertise: Proven track record drafting, submitting,



and managing regulatory submissions (including labelling requirements) for Health Canada approval (Canadian Food & Drug Regulations and Natural Health Product Regulations).
- Leadership: Demonstrated experience managing multidisciplinary teams, leading cross-functional projects, and directing industry stakeholders.
- Asset: Hands-on experience with US FDA regulatory frameworks.

Competencies & Soft Skills

- Commercial & Strategic Acumen: Proven ability to align robust regulatory strategies with commercial business objectives and consumer package development processes.
- Problem Solving & Agility: Cutting-edge problem solver and agile decision-maker who thrives under changing regulatory landscapes.
- Communication & Influence: Excellent oral/written communication skills with strong presentation, negotiation, and stakeholder management abilities.
- Team & Culture Builder: Ability to deliver constructive feedback, navigate conflict, foster team collaboration, and maintain a positive, growth-oriented mindset.

Working Environment

- Work Location: Remote within the Greater Toronto Area (GTA) [and adjacent communities] with occasional in-person meetings for strategic sessions, leadership alignments, or team events.

How to Apply

If you are a strategic regulatory leader ready to shape the future of a growing consulting practice, please submit your resume and cover letter detailing your Health Canada experience and leadership background.

Equal Opportunity Employment

Quality Smart Solutions is an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We encourage applicants from all backgrounds, regardless of race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or any other characteristic protected by law. We believe in providing equal opportunities for employment, advancement, and career development to all individuals.

If you require accommodations during the application process, please contact us at [email protected], and we will work to ensure that your needs are met.

Pay: $95,000.00-$110,000.00 per year

Benefits:

- On-site parking
- Work from home

Work Location: Hybrid remote in Burlington, ON L7L 6A3

📌 Manager, Regulatory Affairs (Burlington)
🏢 Quality Smart Solutions
📍 Burlington