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Regulatory Affairs Director
2 months ago
CPS, Inc. (Food & Beverage Division) is seeking a highly skilled and experienced Regulatory Affairs Director to join our team. As a key member of our organization, you will play a critical role in ensuring compliance with US and international regulations, driving strategic regulatory guidance, and shaping new product innovation.
Key Responsibilities:- Regulatory Affairs Liaison: Serve as the primary point of contact for all innovation projects, providing expertise in nutrition science, scientific substantiation for claims, and regulatory compliance.
- Strategic Regulatory Guidance: Drive regulatory guidance, identify and evaluate regulatory risks, mitigations, and contingencies to ensure compliance with US and international regulations.
- Regulatory Compliance: Simplify complex regulations, directives, and guidance into easily understandable information for consumers and stakeholders.
- Emerging Trends and Developments: Stay updated on emerging trends and developments in domestic and international policies and regulations within our industry.
- Scientific and Professional Associations: Engage in scientific and professional associations to advance CPS, Inc. s Nutrition & Regulatory agenda.
- Mentorship and Training: Mentor and train the Regulatory team to ensure ongoing competence in quality systems and regulatory matters.
- Regulatory Approvals: Oversee regulatory approvals and processes for ingredients, products, packaging, claims, and communications.
- Project Management: Manage regulatory aspects of projects to meet timelines and deliverables.
- Stakeholder Collaboration: Represent the Regulatory function, collaborating with Marketing, Sales, International Sales and Supply Chain leaders.
- Business Development: Cultivate relationships with internal and external stakeholders, collaborating on plans and solutions.
- Trade Secrets: Safeguard business trade secrets internally and externally.
- Regulatory Responses: Coordinate and prepare regulatory responses to authorities requests for information.
- Experience: 10+ years of experience in Regulatory Affairs and Food Safety within the Food & Beverage sector.
- Leadership Experience: Minimum 6 years of leadership experience developing and driving high-performance teams.
- Regulatory Expertise: Profound expertise in regulatory and food law spanning State and Federal levels (FDA, USDA, DPHS, FTC), and international standards (CFIA, FSA, FSANZ, EU), including familiarity with third-party certifying organizations in the Food & Beverage industry.
- cGMP and FDA Guidelines: In-depth comprehension of cGMP, FDA guidelines, and multinational regulatory norms.
- Regulatory Environment: Extensive understanding of the regulatory and political environment impacting the Food and Beverage industry.
