Director, Regulatory Affairs

Job Summary: 

The Director Regulatory Affairs is responsible for leading the development and implementation of global regulatory strategies for the company's products to ensure compliance with applicable domestic and international regulatory requirements.

Job Expectations:

• Provide regulatory direction, guidance, and strategy to ensure compliance with all appropriate government regulations and industry guidelines 
• Determine regulatory submission requirements (i.e., product registrations, certifications, or notifications)  according to domestic and international regulations related to changes/new products/claims
• Oversee, prepare, and manage various submissions and responses to regulatory authority questions ensuring adherence to national and international regulations and standards (i.e., FDA, Health Canada, European Union)
• Anticipate and advise on future regulatory trends and direction, and frequently recommend preemptive approaches for company regulatory compliance.
• Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements and protocol 
• Review proposed labeling to ensure that the intended use and claims are supported and domestic and international regulations are met
• Review documents for regulatory submissions with attention to detail for quality, regulatory compliance, technical merit, and strategic alignment
• Review promotional material and labeling content to ensure compliance with regulatory requirements, consistency, and accuracy
• Compile data and documentation necessary for periodic reports for regulatory filings
• Manage regulatory staff and consultants in key international markets
• Participate in compliance activities that relate to the department and the company 
• Collaborate with public policy, product development, legal, quality & compliance teams as appropriate on regulatory issues
• Provide risk assessments as needed
• Assist with Ad Hoc duties and projects

Knowledge, Skills and Abilities:

  Required:

• Expertise in technical regulations related to dietary supplements, foods, sports nutrition, nutraceutical, or personal care products 
• Expertise in communicating and interpreting regulatory challenges 
• Proven experience in developing regulatory strategies and managing regulatory submission
• A solution-oriented mindset, providing strategic regulatory recommendations for advancements
• Strong collaboration skills with talent to communicate across cultures, influencing stakeholders
• Experience leading cross functional teams through risk management scenarios
• Experience with new product development and/or engineering change process 
• A hands-on approach with a focus on problem solving and finding creative solutions

Preferred:

• RAPS certification desirable, or experience with food/nutrition laws and/or requirements
• Experience with cross-border e-commerce sales

Equipment Knowledge: 

• Experience with Microsoft Office Suite (Word, Excel, PowerPoint)
• Experience with Google Business Suite (Gmail, Drive, Docs, Sheets, Forms) preferred

Experience Requirements:

Minimum 10 years of scientific background in Regulatory Affairs, or related regulatory or compliance function, with use of analytical and scientific databases

Education Requirements: 

BS degree in Food Science, Regulatory Science, Biology, Chemistry, Engineering, or a related sciences discipline (MS degree preferred)

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