Description
About Quality Smart Solutions: 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.
We are seeking an experienced and dynamic Regulatory Solutions Specialist to join our team. This role will focus on regulatory submissions and quality assurance activities, with a particular emphasis on Natural Health Products (NHPs), supplemented foods, cosmetic products, Site License (SL) amendments, and QA product release under our Quality Importation Services (QIS) division.
Regulatory Submissions (NHPs, Supplemented Foods, Cosmetics): Prepare and submit regulatory applications in compliance with Health Canada requirements, ensuring timely and accurate filings across product categories.
Site Licence (SL) Amendments: Manage SL amendment applications and updates, ensuring facilities remain compliant with evolving regulatory requirements.
QA Product Release (QIS): Conduct quality assurance reviews and product release activities for Quality Importation Services, ensuring imported products meet regulatory and quality standards.
Client Consulting & Communication: Act as a strategic advisor to clients, providing expert regulatory and quality guidance with a focus on efficient, practical solutions.
Health Canada Liaison: Communicate with regulatory authorities to address inquiries, resolve issues, and facilitate licensing and product approvals.
Project Management Under Pressure: Manage multiple client projects and deadlines simultaneously, maintaining high accuracy and responsiveness in a fast-paced environment.
Cross-Functional Collaboration: Work closely with internal and external stakeholders to align regulatory and quality priorities with broader business goals.
Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality Assurance, or a related field.
Industry Experience: Minimum 5 years of regulatory and/or quality assurance experience, ideally within a consulting or fast-paced, multi-client environment.
Regulatory Knowledge: Strong understanding of Canadian regulations for natural health products, supplemented foods, cosmetics, and site licensing.
Submission Experience: Proven experience preparing and submitting regulatory filings to Health Canada, including SL amendments and product licensing.
QA Expertise: Familiarity with quality assurance processes related to product release, especially within importation frameworks like QIS.
Excellent written and verbal communication skills, with the ability to explain complex regulatory concepts clearly to clients.
Client-focused with strong problem-solving skills and a solutions-oriented approach to regulatory challenges.
Team Collaboration: Comfortable working collaboratively with internal teams and mentoring junior staff, contributing to a supportive team environment.
Quality Smart Solutions is an Equal Opportunity Employer. We encourage applicants from all backgrounds, regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or any other characteristic protected by law.
