Regulatory Solutions Specialist

Quality Smart Solutions; Ontario; On-site; CAD 60,000 - 75,000; Full time

Job summary

Quality Smart Solutions seeks a Regulatory Solutions Specialist to empower organizations with regulatory compliance and quality assurance in the health product sector. This role requires a proactive consultant with a minimum of 5 years of experience and an educational background in life sciences to ensure that regulatory submissions meet Health Canada standards, while guiding clients through complex processes. Join a team committed to client satisfaction and professional growth.

Benefits

Competitive compensation structure.

Opportunities for personal and professional growth.

Fast-paced work environment fostering learning.

Clear opportunities for career advancement.

Qualifications

• Minimum 5 years of regulatory and/or quality assurance experience.
• Strong understanding of Canadian regulations for natural health products and cosmetics.
• Excellent written and verbal communication skills.

Responsibilities

• Prepare and submit regulatory applications in compliance with Health Canada.
• Manage Site Licence amendment applications and updates.
• Conduct quality assurance reviews and product release activities.

Skills

Regulatory Knowledge

Communication Skills

Time Management

Problem-solving

Client-focused

Education

Bachelor’s degree in Life Sciences, Regulatory Affairs, or Quality Assurance

Job description

Direct message the job poster from Quality Smart Solutions

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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.

Position Summary

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.

Detailed Responsibilities

• 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.

Qualifications:

• Education: 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.
• Communication Skills: Excellent written and verbal communication skills, with the ability to explain complex regulatory concepts clearly to clients.
• Time Management: Demonstrated ability to manage multiple deadlines and prioritize tasks effectively in high-pressure situations.
• Consulting Mindset: 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.

We’re looking for exceptional skills and experience because we offer competitive compensation and benefits, including:

• Competitive compensation structure.
• Opportunities for meaningful personal and professional growth, where your unique background and experience are valued.
• Fast-paced work environment that fosters continuous learning and development.
• Clear opportunities for career growth and advancement.

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, colour, 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 professional development to all individuals.

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Sales and Business Development

• Industries

  Business Consulting and Services

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