Dietary supplement product development and lifecycle managementClaims development (structure function, nutrient content, features & benefits, etc.)Claims risk assessmentsAdvertising guidance (FTC, NAD/BBB), including endorsements, testimonials, influencersDietary supplement labelingRetailer Standards (Amazon, Whole Foods Market, Target, etc.)Certifications (USDA National Organic Program [Handling, Labeling, Certification, Audits], Non-GMO Project Verification, Vegan Action Certification, NSF Certifications [Dietary Supplement Program; Gluten Free], Certified Glyphosate Residue Free / The Detox Project, Halal)Good Manufacturing Practices (cGMP 21 CFR Part 111) - Specifications, Change Management, Adverse Event Reporting, Personnel Training, Documentation ControlCanada Natural Health Product Regulations - Product Licensing, Site Licensing, Post-Market Compliance

Responsible for compliance of dietary supplements with federal, state and international regulations and third party standardsLead and manage technical, legal and retailer challengesMonitor and communicate regulatory intelligence to the business and actively participate in agency influencing efforts. Advocate opportunities to business stakeholders to make regulatory compliance a business advantageCollaborate in the development and implementation of strategies; help determine and meet business goalsAs the head of the Regulatory Affairs department, I built a strong and capable regulatory team from scratch. Responsible for hiring, performance management and ongoing professional development of 3-4 regulatory specialists. As a service-oriented leader I look for opportunities for each team member to grow and shine in their strengthsCollaborate with marketing on advertising and social media campaigns, brand stories, website content, product features & benefits, providing a balanced approach to meeting consumers’ needs while mitigating riskLead teams and help individuals overcome a variety of obstacles, from challenges with qualifying suppliers or materials to addressing quality issues, retailer policies or brand reputation threatsEvaluate and approve proposed changes to formulas, ingredients, materials, and processes to ensure a common sense approach that fits overall company prioritiesEstablish process improvements, effective systems. Implement simple and effective policies to ensure consistent and aligned approachesLead organic certification and annual audit. Act as the company’s liaison with certification organizations and retailers’ and int’l distributors’ compliance leaderCreate the department budget and monitor spendingRegular communication with direct reports and stakeholder colleagues to ensure cross-functional collaboration and to prioritize activities

Provide expert guidance to the business on complex regulatory issues related to dietary supplements. Implement business strategies within the scope of the regulatory department.Responsible for regulatory compliance of dietary supplements in regions such as the United States, Mexico, Middle East, Asia, CaribbeanResponsible for hiring, performance management and ongoing professional development of a team of 4-8, including Regulatory Specialists, Junior Lawyers and Interns/Contractors. I transformed the regulatory function by building a strong collaborative team with excellent regulatory acumen and implementing process improvementsProvide regulatory information, guidance and strategy for new product development and planning throughout the product life cycle, from ideation to development, launch, post-launch maintenance and discontinuationProblem solving of technical regulatory challenges related to supply, manufacturing, GMP, Prop 65 and retailer standardsOversee regulatory compliance of international businessCollaboration with international distributors and internal stakeholders to meet business objectivesBenefit claims guidance, review and approvalOrganic certification - ingredient, formulation and label complianceDietary supplement label development, review and approvalDevelop and approve dietary ingredient and finished product specifications and provide feedback on changes to master batch recordsWrite standard operating procedures and compliance policiesCreate the regulatory department budget and monitor spendingStreamline processes and simplify systemsMonitor and communicate regulatory intelligence to assist in the development of business and compliance plansRegular communication with direct reports and stakeholder colleagues to ensure cross-functional collaboration and to prioritize activities

Natural health product and site licensing activities for Canadian businessEvaluate and provide guidance on formulations, ingredients and co-write specifications for compliance with regulations in target markets and to maintain coherence with dietary supplement labels and claims.Develop, review and approve dietary supplement labels compliant with target market / country.Structure function and product claims development and approval

In 5 years I was instrumental in growing the international business to 25% of the growth of the company, 20% of the revenues and 30% of the profit. I developed 5 food supplement formulas for the European market.I was one of three employees who established New Chapter Canada in 2011.Primary focusResponsible for all technical and regulatory requirements (ingredient, formulation, labeling, registrations/notifications, etc.) to meet or exceed international business goals in the following regions: Canada, United Kingdom, Belgium, France, Netherlands, Sweden, Norway, DenmarkUnited Arab Emirates, Kuwait, Hungary, South Africa, Lebanon, Israel, Hong KongSupport the Quality team’s GMP goals; managed change control, wrote standard operating procedures, and conducted GMP trainings for all employees

Responsible for determining viable business opportunities to sell compliant dietary supplements outside the US. This required learning about and reporting on regulatory and other requirements to legally commercialize in the target market and determine whether internal capabilities could support those requirements. Developed strategies with internal and external partners. Worked closely with international distributors.

Active public speaker representing the cinema. Responsible for building the business from ground up including hiring all staff, scheduling staff hours and film programming; the planning and execution of special film programming. Managed the house, daily reporting to distributors. Ordered all goods, managed vendor relations; inventory. Daily website updates and creation of publicity materials. Collaborated with educators in the 5-College system on programs.