About Company
Hiring.zycto is at the forefront of connecting top-tier talent with groundbreaking opportunities in the life sciences sector. We understand the critical importance of regulatory compliance and innovation in bringing essential products to market. For a Health Canada Reviewer, our environment offers unparalleled exposure to diverse projects and a culture that champions precision, analytical rigor, and continuous professional growth. We are dedicated to fostering careers where impact is measurable and expertise is highly valued. Join a dynamic team committed to shaping the future of health regulations and product safety.
Job Description
Are you a meticulous regulatory professional with a passion for public health and a deep understanding of Health Canada’s regulatory framework? Hiring.zycto is seeking a dedicated and experienced Health Canada Reviewer to join our client’s expert team in Heatherglen, Spruce Grove. This is an exceptional opportunity for an individual who thrives in a detail-oriented environment and is committed to ensuring the safety, efficacy, and quality of health products for Canadians. As a Health Canada Reviewer, you will play a pivotal role in navigating the complex landscape of regulatory submissions, providing critical analysis, and facilitating the approval process for a wide range of products including pharmaceuticals, medical devices, natural health products, and more.
In this full-time on-site role, you will leverage your expertise in Canadian regulatory guidelines to critically evaluate scientific and technical data, ensuring all submissions meet Health Canada’s stringent requirements. You will be responsible for identifying potential compliance issues, offering strategic insights, and collaborating closely with cross-functional teams, including R&D, Quality Assurance, and Legal, to address deficiencies and drive successful outcomes. This position demands a keen eye for detail, strong analytical capabilities, and excellent communication skills to articulate findings and recommendations effectively to stakeholders and regulatory bodies.
The ideal candidate will possess a comprehensive understanding of the Food and Drugs Act, its regulations, and relevant guidance documents. You will be expected to stay abreast of evolving regulatory landscapes and contribute to the continuous improvement of internal processes. This role offers a chance to make a tangible impact on the accessibility of safe and effective health products, working within a supportive and collaborative setting. If you are ready to apply your regulatory expertise in a challenging yet rewarding capacity, we encourage you to apply and become an integral part of a team dedicated to excellence in regulatory compliance. This is more than just a job; it’s a chance to contribute significantly to public health in Canada.
Key Responsibilities
- Conduct comprehensive reviews of regulatory submissions (e.g., DIN, NDS, ANDS, MDL, NHP) for pharmaceuticals, medical devices, and natural health products to ensure compliance with Health Canada regulations and guidance documents.
- Critically evaluate scientific and technical data, including chemistry, manufacturing and controls (CMC), non-clinical, and clinical sections, to assess product safety, efficacy, and quality.
- Identify regulatory deficiencies, formulate detailed queries, and communicate effectively with applicants and internal teams to resolve issues.
- Provide expert regulatory advice and strategic input to project teams on product development and lifecycle management, ensuring adherence to Canadian requirements.
- Prepare detailed review reports, briefing documents, and recommendations for regulatory decisions.
- Monitor and interpret new and evolving Health Canada regulations, policies, and guidelines, and assess their impact on current and future submissions.
- Participate in meetings with Health Canada officials and represent the client's interests during regulatory interactions.
- Maintain accurate and up-to-date knowledge of the Food and Drugs Act and associated regulations.
Required Skills
- Minimum of 3 years of progressive experience in regulatory affairs within the pharmaceutical, medical device, or natural health product industries in Canada.
- Demonstrated expertise in Health Canada regulations (e.g., Food and Drug Regulations, Medical Devices Regulations, Natural Health Products Regulations).
- Strong analytical and critical thinking skills with the ability to interpret complex scientific and technical data.
- Exceptional written and verbal communication skills, with the ability to clearly articulate regulatory positions and review findings.
- Proficiency in preparing comprehensive regulatory documents and reports.
- Bachelor's degree in a life science, pharmacy, chemistry, or a related field.
- High level of attention to detail and accuracy.
- Ability to work independently and collaboratively within a team environment.
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific discipline.
- Certification in Regulatory Affairs (e.g., RAC).
- Experience with eCTD software and electronic submission processes.
- Familiarity with international regulatory guidelines (e.g., FDA, EMA) is an asset.
- Experience in a reviewing capacity, directly interacting with regulatory agencies.
Perks & Benefits
- Competitive salary package.
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holidays.
- Professional development opportunities and tuition reimbursement.
- Matching retirement savings plan.
- On-site parking.
- Employee assistance program.
- Collaborative and supportive work environment.
How to Apply
Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and qualifications by clicking on the application link below. Please ensure your application highlights your expertise in Health Canada regulatory review processes.
