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Director of Regulatory Affairs
2 months ago
WHAT WE ARE LOOKING FOR:
The Director, Regulatory Affairs will serve as the leading expert in Scientific & Regulatory Affairs, overseeing all facets of U.S. and international regulations (EU, CAN, AUS, and others), alongside the management of 3rd party certifications for our entire product portfolio. A successful Director, Regulatory will establish credibility through their expertise in navigating complex regulatory landscapes, demonstrating exceptional leadership skills by building and mentoring a world-class team. Lastly, this individual will drive best practices in regulatory compliance and actively shape new product innovation, leveraging their strategic mindset and extensive nutrition and regulatory knowledge to ensure product integrity and market compliance.
KEY RESPONSIBILITIES:
• Serve as the key Regulatory Affairs liaison for all innovation projects, offering expertise in nutrition science, scientific substantiation for claims, and regulatory compliance.
• Drive strategic regulatory guidance, identify and evaluate regulatory risks, mitigations, and contingencies.
• Simplify complex regulations, directives, and guidance into easily understandable information for consumers and stakeholders.
• Stay updated on emerging trends and developments in domestic and international policies and regulations within our industry.
• Engage in scientific and professional associations to advance the Company's Nutrition & Regulatory agenda.
• Mentor and train the Regulatory team to ensure ongoing competence in quality systems and regulatory matters.
• Ensure compliance with US Regulations by interpreting regulations and science to support claims.
• Oversee regulatory approvals and processes for ingredients, products, packaging, claims, and communications.
• Manage regulatory aspects of projects to meet timelines and deliverables.
• Represent the Regulatory function, collaborating with Marketing, Sales, International Sales and Supply Chain leaders.
• Lead regulatory activities ensuring compliance with US, European, Canadian, Australian, and other relevant requirements.
• Cultivate relationships with internal and external stakeholders, collaborating on plans and solutions. • Safeguard business trade secrets internally and externally.
• Coordinate and prepare regulatory responses to authorities' requests for information.
KNOWLEDGE / ABILITIES:
• Proficient in managing intricate regulatory challenges impacting products, ingredients, packaging, and claims.
• Apply sound judgment and decision-making skills, rigorously testing assumptions and facts while remaining aligned with available information and potential outcomes.
• Analytical expertise around current processes and adept methodologies that identify efficiencies and achieve objectives.
• Proficient in exploring diverse perspectives and solutions to achieve mutually beneficial outcomes, fostering a culture of collaboration and win-win scenarios.
• Exceptional attention to details and strong communicator - written and verbal; Embraces innovative and unconventional thinking, complemented by a deep understanding of scientific and Food & Beverage trends, vital for effective leadership.
BASIC QUALIFICATIONS:
• Demonstrated 10+ years of experience in Regulatory Affairs and Food Safety within the Food & Beverage or Supplement sector; Minimum 6 years of leadership experience driving high performance teams.
• Profound expertise in regulatory and food law spanning State and Federal levels (FDA, USDA, DPHS, FTC) as well as international standards (CFIA, FSA, FSANZ, EU), including familiarity with third-party certifying organizations in the Food & Beverage industry.
• In-depth comprehension of cGMP, FDA guidelines, and multinational regulatory norms.
• Extensive understanding of the regulatory and political environment impacting the Food and Beverage industry.
This hybrid (T-TH) role with a leading Better-For-You food manufacturer includes an annual Short Term Incentive of 25% and a Long Term Incentive of 20%
