Director, Regulatory Affairs International – (KSS_DRM_2021)
This position located in Muscatine, Iowa is responsible for providing leadership and direction in all aspects of regulatory compliance activities of assigned projects for export sales of Kent Corporation and its subsidiaries’ products in international markets. They will lead in the preparation and compilation of regulatory submissions, managing processes and timelines, and collaborating with other departments and regulatory individuals throughout the organization in accordance with regulatory strategies and in compliance with regulatory agencies.
This role will not have direct reports but will work with other Kent business unit regulatory personnel as needed.
PRIMARY DUTIES & RESPONSIBILITIES:
- Provides strategic regulatory oversight, identifies opportunities, risks and mitigations associated with regulatory projects and strategies for Kent’s International Sales Team
- Collaborates with the Kent Corporation Legal Department’s Director of Regulatory Affairs subject matter expert to obtain guidance and understand the company’s position on regulatory affairs, and strategic regulatory options to ensure alignment of regulatory strategy to business strategy within the International Sales Team
- Ensures regulatory compliance in the markets where the organization has a business interest internationally
- Monitors proposed legislation and regulations for possible impact and effect on international regulatory compliance activities
- With consultation of R&D, Legal, and others as required will be responsible for creating and updating ingredient declarations and nutrition panels for both new and existing products
- Create, manage and update all appropriate regulatory documents (ex: allergen, GMO, Country of Origin, % range breakdown, customer questionnaires, gluten, natural, SDS, etc.)
- Maintain working knowledge and understanding of existing and emerging food and labeling regulations that will or may affect the international sales of Kent’s product offerings
- Understand rules set out by government and certifying organizations including, but not limited to GMO, Kosher, Halal and Organic
- Responsible for simultaneously managing multiple deadlines and projects
- Provides regular reporting and support to Kent’s International Sales Team
- Ensure regulatory compliance with food safety, food defense, and food quality as it relates to the FDA (CFR106, CFR117, CFR110), DEA, FSMA, USP, FCC, GFSI (BRC), shares with other regulatory individuals across the organization
- Travels as needed to visit customers, attend tradeshows, industry events and company meetings
• Business acumen
• Strong ethics and values
• Strong integrity and builds trust with others
• Is able to build strong peer relationships
• Exceptional at communications in any form
• Able to set appropriate priorities and actionable plans
• Has technical competence in regulatory field
• Deals well with ambiguity
EDUCATION & QUALIFICATIONS:
• Bachelor’s Degree in a life sciences or related fields
• 10+ years of regulatory affairs experience or related discipline
• Experience working in regulatory function is preferred in the food/beverage and feed industries
• Proven track record with US regulatory processes and documentation
• Preference given to individual with direct experience in governmental agencies such as FDA, USDA, or similar federal regulatory agencies.
• Strong knowledge of regulatory policy; excellent scientific and business judgment.
• Strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills.
• Experience developing and delivering effective regulatory and management presentations.
• Demonstrated ability to creatively solve complex problems and deal with issues and challenges with effective solutions.
• Genesis Nutrition software knowledge and skills a plus
This role will be based in Muscatine, Iowa and is part of the Kent Corporation Shared Services group within the International Sales Team. The role will work collaboratively with the regulatory and quality team at all Kent business units.
Learn more here
Job posted: 2021-03-18