True North Nutrition - Regulatory Affairs Specialist
Richmond Hill, ON
On January 10, 2018
True North Nutrition is one of Canada’s leading distributors in the natural health food and sports nutrition industry. Specializing in sales, marketing and distribution of these products, we work with many retail partners and independent health stores to achieve outstanding sales results. Recognized by Profit 100 as one of Canada’s fastest growing companies, we are truly an industry leader offering excellent career opportunities to individuals looking for a rewarding and challenging job. Our head office and distribution center is located in Richmond Hill, Ontario and we employ a national sales force across the country.
We are currently seeking a highly motivated Regulatory Affairs Specialist to join our growing team. Reporting to the President, this role will provide regulatory support to internal and external customers and will oversee all regulatory issues for all health and wellness/ sport nutrition products. This will include ensuring regulatory compliance with Health Canada and also for the timely approvals for all product brands by coordinating, preparing and managing all product submissions.
DUTIES AND RESPONSIBILITIES:
- Provides input on regulatory-related issues associated with compliance and achieving a business plan for all brands.
- Prepare and/or review submissions for natural health and sports nutrition products forms to Health Canada (i.e. NPN, site licenses)
- Prepare and/or review responses to product recalls or audits.
- Oversee adherence to Quality Assurance SOP's and provide recommendations for improvements where necessary.
- Assist in the regulatory review of regulatory labeling and promotional materials to ensure compliance with Canadian/provincial regulations.
- Provide the management team with regular updates on product registration including preparing management reports which include current status of submissions and other regulatory issues for management review.
- Ensure product submissions are reviewed and renewed as required.
- Ensure post-market regulatory requirements for respective brands are met
- Establish and implement plans to maintain a trusted relationship with Health Canada through regular meetings, discussions, training and education.
- Arrange and complete product license applications for submission to Health Canada.
- Consult on French translations for product packaging and packaging inserts.
- Assist in negotiations with Health Canada to ensure a prompt regulatory approval.
- Arrange for laboratory analysis as necessary.
- Review Change Controls and determine filing requirements.
- Maintain current awareness for regulatory guidelines (Health Canada, CHFA, FDA, etc.) including reviewing regulatory publications and disseminate relevant regulations, guidelines and policies to other departments within the Company to ensure that all development programs and post-approval activities are based on current regulatory requirements.
- Other duties as required.
- Bachelor's degree in a scientific discipline from a four-year college or university will be an asset.
- At least 2 years Regulatory Affairs experience working in a regulated natural health/ sports nutrition environment or a recent graduate of a Regulatory Affairs Program from a certified college (eg., Humber or Seneca Program)
- Excellent knowledge of Health Canada regulations
SKILLS AND ATTRIBUTES:
- High attention to detail
- Strong interpersonal skills and ability to work in a cross-functional team environment
- Ability to work in a fast-paced environment with time sensitive deadlines
- Ability to work independently
- Strong organization, multi-tasking, time management skills
- Strong communication skills (written and verbal)
- Advanced Excel skills
- Experience using online data portals
- Must be able to pass a Criminal Records Check
True North Nutrition offers competitive compensation and benefits, if you are interested in joining our team; please forward your resume to email@example.com
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