Regulatory Affairs Specialist

• 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
• All other duties as required.

• Successful completion of Bachelor of Science (Food / Nutrition Science/ Toxicology preferred); Master of Science preferred
• Prior 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;

• Flexibility, Agility, Adaptability: Thrives in dynamic environments by embracing continuous change. Quickly adjusts to new priorities and actively seeks innovative solutions. Uses setbacks as opportunities for growth
• and applies a relentless focus on improving outcomes. Approaches challenges with a proactive, solutions-driven mindset and openness to feedback.
• Calculated Risk-Taking: Makes strategic decisions by evaluating options and creating contingency plans.

• Team First and Collaboration: Engages with Team Members and colleagues, builds relationships, and fosters an inclusive, innovative environment.

• Continuous Improvement: Drives innovation and optimizes processes to enhance quality and productivity.
• Customer and Product Focus: Addresses need proactively with accountability and a solution-oriented mindset.
• Fierce Execution: Achieves results with a strategic and hands-on approach, learning from mistakes and building trust.

• Continually inspires and develops Team Members​ and promote cross-functional collaboration.

• Supports, shared knowledge and experience with your Team through authentic conversations and development planning
• Communicates clear expectations​
• Uses insight and knowledge to influence others​
• Understands and acknowledge differences and modifies style to support unleashing potential
• Demonstrates patience and empathy, while listening​

• Inspire enthusiasm & commitment by communicating a clear path to success​
• Empowers others by delegating and providing support and opportunities for growth​
• Identifies, raises and resolves conflict​
• Builds trust and models the “Coach Approach”​

• Encourages informed risk-taking and supports learning from outcomes.
• Creates an environment where your team enjoys working hard while having fun​
• Provides feedback to reinforce results​

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