Regulatory Affairs Manager

The Regulatory Affairs Manager will be the lead of Regulatory Affairs ensuring smooth daily regulatory operations and compliance for Hearthside Food Solutions, which includes Biscuits, CCW, Fresh/Frozen, and Bars. The manager is responsible for empowering their team and providing leadership and guidance as needed to ensure that the team is able to deliver on compliance commitments, internally and externally for their customers. In addition to being responsible for developing and managing the programs and strategies necessary to ensure compliance for product and packaging regulatory for Hearthside Food Solution’s portfolio of food products.

Core Accountabilities:

• Lead and develop a strong team of Regulatory Affairs Associates that are capable of managing complex regulatory issues including sensitive customers in a timely manner
• Direct and supervise all regulatory activities to ensure compliance of new and existing product portfolio (innovations and productivity)
• Ensure business activities comply with applicable regulations and laws in USA and Canada
• Inform and advise business on changing global regulations to determine and mitigate impact on the design and compliance of Hearthside Food Solution’s product line
• Support and manage product incident investigation, resolution and reporting (including Recall management)
• Lead the planning and execution of regulatory-based changes that impact business wide portfolios based on jurisdiction specific requirements.
• Develop and manage strong partnership with trade and industry associations and related organizations, ensuring strategic allocation of resources
• Conduct stakeholder mapping and analysis and identify pathways to advance regulatory priorities (ie. R&D vs Regulatory RACIs)
• Organize and participate in advocacy activities including committees and conferences
• Participate in strategic planning, budgeting and maintenance, including project and external consultant management when needed
• Organize on-going training for internal business partners to ensure understanding of regulatory requirements and how it impacts the business
• Work with internal business partners including product development, marketing, procurement, sales and supply chain, to identify current and future regulatory and compliance needs to support and advance business requirements
• 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.
• Effectively navigate and problem solve issues with the business while appropriately balancing the regulatory requirements and the business based objectives.
• Develop brand specific or company wide regulatory policies/ creative solutions (as needed) guiding the processes and practices for teams to adhere to allowing for successful launch of product lines and overall innovation.
• Execute substantiation and application of claims on all packaging and marketing materials in accordance within all applicable regulations.
  
  

Required Competencies & Knowledge :

Knowledge of:

• Hearthside procurement, products, development and production processes
• Knowledge and experience with SAP, TraceGains, Excel, PowerPoint
  
  

Skill in:

• Must have excellent oral and written communication skills.
• Strong self-confidence.
• Strong will to drive change.
• Excellent problem-solving skills and the ability to work with autonomy.
• Excellent presentation and training skills
• Must be accurate, detail-oriented and maintain the utmost confidentiality.
• Must be detail oriented.
  
  

Ability to:

• Communicate in English to give and acknowledge instructions/problems.
• Physical and mental ability to work in excess of 40 hours per week.
• Ability to calculate figures.
• Ability to add, subtract, multiply and divide in various units of measure, using whole numbers, common fractions and decimals.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Ability to write routine reports and correspondence.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram and/or schedule form.
• Ability to work well with others in stressful situations and meet deadlines as necessary.
• Ability to handle multiple priorities and tasks.
• Excellent keyboarding, record keeping and follow-up skills.
• Ability to work in a fast-paced environment, while at the same time making sound decisions.
  
  

Proficiency in: MS Office Suite and SAP

Minimum Qualifications :

• Successful completion of Bachelor's of Science and/or Master's of Science (Food / Nutrition Science/ Toxicology preferred)
• Prior 5+ years of experience in the field of Regulatory, Nutrition Science and Scientific Affairs with Food and Beverages.
• Established knowledge of Canadian and U.S. government labelling regulatory requirements specific to Health Canada, Canadian Food Inspection Agency, U.S. Food and Drug Administration
• Experience with Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP), GFSI all pluses
  
  

Founded in 2009 and headquartered in Downers Grove, IL we are a world-class contract manufacturer producing wholesome baked goods, snacks and packaged foods for many of the world’s leading food companies. As one of the largest and fastest growing food co-manufacturing companies in the US, we are the proud owner and operator of over 35 facilities globally. Our nearly 10,000 employee-strong organization is leading the way and setting new standards for quality, safety, flexibility and efficiency while feeding families around the globe.

Hearthside’s exceptional growth stems from its ability to address real-world problems for customers of all shapes and sizes, and by our resolute commitment to our belief that there are no great companies without great culture. Our culture of personal empowerment enables growth, learning, and continuous improvement every day!

We are steadfast in our ambition to be the indispensable and most trusted partner to our customers and need your help to do it! Join Hearthside and enjoy a competitive package, outstanding benefits and a diverse work environment.

Hearthside is an Equal Opportunity Employer.

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