Senior Regulatory Affairs Manager

Vireo Systems & pHD Feminine Health are fast-growing, innovative companies that are revolutionizing global health. We have a dynamic team that is passionate about improving the lives of people by delivering premium, healthy products through world-class research, innovation, and manufacturing. 

POSITION SUMMARY:

We are seeking an innovative and detail-oriented Senior Regulatory Manager to join our health and wellness team. The Senior Regulatory Affairs Manager will provide regulatory leadership for food and dietary supplements with a background in nutrition. This role will also contribute to the company’s scientific reviews of nutrition opportunities, translation of science to product opportunities, develop programs to support internal and external nutrition education, and develop tools needed to monitor progress. A key accountability of the position is to protect Vireo Systems, its customers and consumers from non-compliant allergen, nutrition, ingredient and health claim declarations on package labeling, print and television advertising, and websites.

LOCATION: Remote or Hybrid

ROLES AND RESPONSIBILITIES: 

Project Leadership

• Provide technical and regulatory direction and guidance to ensure all packaging, website content and sales materials are accurate and compliant with applicable laws and regulations
• Develop and maintain partnerships across the organization and engage with external partners serving as a resource to address and ensure regulatory compliance of emerging or changing nutritional and labeling regulations and trends
• Develop claims framework based on clinical research and scientific literature on pack and digital for both brands, ensuring adequate substantiation for compliance with all regulatory agencies to protect the brands while driving growth.
• Collaborate with internal partners, including Quality Assurance, Development, Legal, Marketing, and Purchasing, to resolve compliance issues and manage regulatory, food safety, litigation, brand and third-party risk
• Develop and issue internal regulatory policy and guidance documents
• Evaluate labeling impact of product reformulation to inform packaging transitions and product/package disposition decisions
• Oversee the development and maintenance of product nutrition facts panels, ingredient declarations and allergen statements to ensure compliance with federal regulations, third-party certification or customer standards, and company policies
• Review label verification audit results and identify the severity of audit findings or the risk associated with the findings to ensure the appropriate level of action is taken to eliminate non-compliance
• Use deep regulatory insight to solve problems and identify compliant solutions as a proactive business partner throughout the product’s lifecycle
• Manage and track all regulatory submissions, including FDA 30-day notices for structure/function claims, product information/labels for Dietary Supplements

 Required Qualifications

• Bachelor’s in food science, nutrition or related field
• 10 years of experience in regulatory affairs and nutrition in food & beverage industry
• Knowledge of FDA, FTC, NAD and applicable USDA regulations
• Demonstrated experience in building processes and identifying and resolving regulatory issues quickly and effectively
• Knowledge of regulatory frameworks and nutrition science
• Prior experience working on new products and/or execution of new products is preferred
• Excellent oral, written, and presentation communication skills are required
• Demonstrated leadership & influencing skills across organizational levels is required
• Current with developing laws, regulations, and enforcement activities impacting the use of ingredients, product safety, labeling, and advertising to provide effective regulatory assessment and impact of proposed changes to the business.

Skills And Mindset

• Strong command of the details of relevant regulations and the ability to make regulatory matters understandable and actionable for stakeholders

• Results oriented with an ability to work on multiple tasks and meet deadlines
• Demonstrated risk assessment and problem-solving skills with the ability to implement effective solutions
• A team player with strong interpersonal skills who demonstrates good judgment, initiative, and a sense of urgency.
• Ability to work independently within assigned areas of responsibility

PHYSICAL DEMANDS / WORK ENVIRONMENT:

• Must be able to sit/stand for 8 hours
• Walking, bending, light lifting to 50 lbs