Regulatory Affairs Associate

18 hours ago

Toronto, Canada CanPrev Natural Health Products Ltd. Full time

**About Us**:
CanPrev Natural Health is a dynamic and innovative company dedicated to providing exceptional products in the natural health industry. We grew out of the desire to make natural medicine safe, effective and accessible to everyone. And for close to two decades, we continue to believe and strive to help empower and inspire Canadians to take charge of their health.

**Position Overview**:
This role is ideal for someone looking to grow their career in Regulatory Affairs within the NHP industry. Reporting to the Regulatory Manager, the Regulatory Affairs Associate will assist with ensuring product compliance, supporting label and marketing material reviews, and helping manage Health Canada submissions and safety reporting.

**Key Responsibilities**:

- Review product labels, information sheets, and promotional materials for compliance with Health Canada’s NHP and US FDA dietary supplement guidelines
- Cross-reference product ingredients, dosages, and claims against applicable NHP monographs, Licensed Natural Health Products Database (LNHPD) entries, and approved marketing authorizations to ensure regulatory compliance

**Adverse Reaction Reporting**
- Primary point of contact for Apotex PV team.
- Receive and accurately enter adverse reaction (AR) reports from consumers, healthcare professionals, and retail partners into safety databases in a timely and complete manner, adhering to internal SOPs and regulatory requirements.
- Assist in monitoring follow-up requirements and requesting additional information from reporters as needed.

**Regulatory Submissions**
- Track and update the status of product submissions to Health Canada, ensuring timely responses to information requests (IRNs) or screening deficiencies.
- Document proposed license updates and modifications initiated by the Product Development Team.
- Support the maintenance of internal regulatory databases and submission trackers.

**Documentation & Compliance Support**
- Maintain comprehensive, audit-ready regulatory records, including product licenses, master files, and submission correspondence.
- Assist in compiling and organizing documentation for audits, recalls, and inspections to ensure regulatory compliance and accuracy, as needed.

**Qualifications**:

- Post-secondary education in Life Sciences, Regulatory Affairs, or a related field.
- Up to 2 years of experience in a regulatory, QA, or compliance role (NHP/ supplement experience is a plus).
- Familiarity with Health Canada’s NHP regulations and databases (eg. LNHPD, NHPID) is preferred.
- Detailed-oriented and comfortable working independently in a remote environment with good time management.

**Job Types**: Full-time, Permanent

Pay: $55,000.00-$60,000.00 per year

**Benefits**:

- Dental care
- Flexible schedule
- Paid time off
- Store discount
- Vision care
- Work from home

Work Location: In person

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