SUMMARY:

The Regulatory Affairs Specialist is responsible for ensuring ingredient declaration; nutrition panel, allergen statements and other regulatory elements are accurate and comply with government regulations for Canada and/or US. This includes supporting manufacturing plants in audit preparations; providing information for supplier/co-packers/customer requests as well as updating/maintaining supplier and raw material documentation in our databases.

QUALIFICATIONS:

• Successful completion of Bachelor of Science (Food / Nutrition Science/ Toxicology preferred); Master of Science preferred
• 1-2 years of experience in the field of regulatory compliance and associated labelling requirements
• Established knowledge of Canadian and U.S. government regulations on ingredient, claims and nutritional labelling: up-to-date and respond to initiatives to comply with current and upcoming regulatory changes within Health Canada, Canadian Food Inspection Agency, U.S. Food and Drug Administration, other regulatory agencies as required;
• Knowledge/ experience of regulatory skills in jurisdictions beyond North America, an asset.
• Strong organizational and planning skills; Detail-oriented;
• Excellent analytical skills and problem solving skills; multi-task and prioritize tasks;
• Proficient with MS Office applications (Word, Excel, PowerPoint), SAP and product databases;
• Knowledge / proficiency in Product Vision as asset;
• Can communicate effectively at different levels in the organization and cross functional stakeholders;
• Ability to work under pressure in a changing and fast-paced environment;

• Effectively collaborate with cross-functional stakeholders in the commercialization process by representing the regulatory team with crucial innovation based inputs grounded in the fundamentals of regulatory guidance for packaging and product labelling requirements
• Collaborate with Marketing, R&D, QA, Supply Chain, Packaging, and Manufacturing to coordinate and implement changes to affected specifications and / or labels in response to formula changes and / or new regulations
• Work directly with the R&D team to ensure ingredients and formulations are compliant with the relevant regulatory requirements based on jurisdiction
• Evaluate ingredients, formulas and artwork to ensure compliance to applicable regulations and customer policies
• Generate nutrition and ingredient labels for new and existing finished products using ProductVision; Proofread of labels submitted for verification and ensure nutrition and ingredient labels are electronically available to sales, key account managers, marketing, R&D, and customers inclusive of customer portals
• Organize and manage R&D specific documentation such as technical regulatory specifications according to established company procedures along with applicable databases
• Proofread and approve final copy of all new packaging materials; Maintain updated spreadsheets and databases of packaging artwork files, finished product list, raw materials, and suppliers to ensure adherence to government legislation and customer policies
• Execute substantiation and application of claims on all packaging and marketing materials in accordance within all applicable regulations for Canada and/or US
• Actively update Director of Regulatory Affairs on plans and progress