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Manager, Regulatory Affairs and Quality Control
2 weeks ago
**ABOUT US**
CANADA’S LEADING DISTRIBUTOR OF SPORTS SUPPLEMENTS & NATURAL HEALTH PRODUCTS
We are a fast-growing product distribution company, and our mission has been to introduce innovative, effective products that optimize health and wellness to the Canadian market
**About the Role**:
We are looking for a knowledgeable and detail-driven Manager of Regulatory Affairs and Quality Control to join our team and help ensure our products meet the highest standards of safety, compliance, and quality.
In this role, you will play a critical part in ensuring the regulatory compliance and product quality of our Natural Health Products (NHPs). You will be responsible for leading regulatory submissions to Health Canada, maintaining company licenses, and overseeing product testing, release, and quality systems. This role also serves as the main point of contact with regulatory authorities and works cross-functionally to support product launches, labeling compliance, and GMP adherence in accordance with Health Canada regulations.
**Key Responsibilities**:
- Preparation and submission of Product License Applications to Health Canada / NNHPD.
- Strong experience in communicating with Health Canada regarding Information Request Notices (IRNs), Regulatory and Quality Requests and Audits.
- Act as a main point of contact with Health Canada, MDEL Unit, NNHPD and CFIA.
- Responsible for maintaining status of all the Company Licenses including Site License (SL), Medical Device Establishment License (MDEL) and Safe Food for Canadian Act License (SFCA).
- Oversee finished product release procedure for both domestic and Foreign Sites.
- Oversee Sample Retention, Finished Product Testing and Stability Testing
- Responsible for assessing the quality of Natural Health Products offered for sale in Canada as required by Health Canada cGMP guidance document prior to their release
- You will be required to quarantine products with submission #’s as they arrive, review lot codes, retain samples, send samples for testing, review test results against finished product release specifications and release products according to guidelines set by the NNHPD.
- Responsible for Company Quality Assurance Activities.
- Maintenance and Implementation of SOPs as per Health Canada GMP requirements for Natural Health Products, Supplemented Food Products and Conventional Foods
- Sampling and examination of the finished products.
- Maintenance of Testing Schedules as per NNHPD requirements and Release of all good destined for sale.
- Maintenance of Retained Samples and their Schedules
- Coordinating Stability Testing Program
- Disposition of returned goods (if applicable) as per the local Environmental Regulations
- Lead Product and Customer and Complaint investigations
- Provide co-ordination for implementing of recall when required
- Self-inspection Program
- Review finished product artwork/ labels for dietary supplements (NHPs) and food products for regulatory compliance
- Review and approve product claims and advertising materials
**Position Requirements**:
- Minimum 5 years of experience in a Regulatory Affairs and/or Quality Assurance role within the Natural Health Products (NHPs) or nutraceutical industry
- In-depth knowledge of Health Canada regulations, including NNHPD, MDEL, and SFCA requirements
- Strong understanding of GMP (Good Manufacturing Practices) for Natural Health Products and Food Products
- Familiarity with regulatory compliance for product labels, claims, and advertising
- Experience coordinating product recalls, quality investigations, and customer complaints
- Demonstrated ability to manage sample retention, finished product testing, and stability testing programs
- Proven track record in managing site and establishment licenses (SL, MDEL, SFCA)
- Strong organizational and documentation skills with attention to detail
- Excellent communication skills for interfacing with regulatory bodies and internal teams
- Proficient in writing, reviewing, and implementing SOPs in compliance with Health Canada requirements
- Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality Assurance, or a related field (master’s preferred is a plus)
**Technical & Systems Skills**
- Electronic Document Management Systems (EDMS) - for managing regulatory submissions and SOPs
- Regulatory submission tools - familiarity with Health Canada’s ePost, DPR (Drug Product Database), and NNHPD e-Portal
- Microsoft Office Suite - particularly:
- Excel
- Word
- Outlook
- Adobe Acrobat Pro
**The Peak Advantage**:
- Collaborative, team-oriented work culture with growth opportunities.
- Employee and family discounts on all Peak products.
- On-site gym for employee use.
**Job Types**: Full-time, Permanent
Pay: $80,000.00-$100,000.00 per year
**Benefits**:
- Casual dress
- Company events
- Dental care
- Extended health care
- On-site gym
- On-site parking
Application question(s):
- Minimum 5 year of experience in a Regulatory Affairs and/or Quality
