The Regulatory Director will develop and lead the regulatory organization within Shearer’s Snacks. Will lead a team of regulatory managers and specialists to ensure the organization maintains compliance with all regulatory laws, policies, and programs. Will serve as lead regulatory resource to internal and external customers. Responsible for maintaining and developing, both existing and future, regulatory programs to ensure compliance with all regulatory laws Maintain and assure data integrity of all formulations, nutritional labeling, and all required regulatory record keeping. Responsible for the professional development of the regulatory organization including required continuous education of regulatory programs. Will stay current on regulatory issues and potential laws affecting the business and will use this information to advise the business in setting strategy. Understand, respect, and act ethically in all dealings, especially related to regulatory compliance.
Essential Duties and Responsibilities:
- The Regulatory Director is responsible for applying and implementing regulatory strategies and policies by using exemplary collaboration with other departments and functions.
- Manage and direct the regulatory department
- Establish and maintain policies and procedures to ensure company and department compliance with all applicable local, state, federal and other regulations as required.
- Develop and implement regulatory management strategies and plans, including resources, systems, processes to support, contribute to, and integrate within the organizations business plan and long term strategy.
- Ensure alignment of regulatory strategy to business strategy across all functional areas
- Provide strategic input to executive management
- Identify, assess and recommend corrective action measures associated with regulatory matters
- Enhance regulatory management systems to facilitate overall regulatory compliance
- Oversee preparation and submission of accurate, well-organized, effective regulatory filings for products, packaging, labeling or other regulatory clearances to the FDA and other government agencies
- Foster and maintain cooperative relationships with regulatory authorities to facilitate interactions on behalf of the company
- Understand, respect, and act ethically when dealing with matters related to regulatory compliance.
- Demonstrate resourcefulness, self-sufficiency and ability to adapt to a fast paced environment
- Stay current on legislation or regulatory issues that may affect the business.
- Manage communication with outside legal counsel on resolution of regulatory issues when appropriate.
Professional Development of Regulatory Department:
- Provides leadership, support and coaching for regulatory department.
- Plans, promotes, and organizes ongoing education and training activities to ensure regulatory compliance.
- Conducts regular individualized meetings to provide feedback on performance.
- Partner with the regulatory department to help them achieve their career development.
Deliver Cross Functional Collaboration:
- Builds relationships across other functional teams to assure effective communication and efficient task completion.
- Build relationships cross functional partners to assure positive work place
- Heighten awareness of potential regulatory pit falls that could affect the goals of cross function teams
- Effectively communicate regulatory reasoning and appropriate recommendations on regulatory positions to cross functional department heads, executives, and external customers
- Participate in special projects and team meetings across the organization
Knowledge, Skills, and Abilities; Education; and/or Work Experience Requirements:
- Bachelor’s Degree in Food Science, Animal Science, Nutrition, Biology, Chemistry or other related field is required.
- Master’s Degree Preferred or 10+ years of education and relevant experience combined
- Relevant work experience in regulatory, quality, or research & development (or a combination) within the food & beverage industry.
- Experience with FDA required and knowledge of USDA and CFIA preferred
- Experience with FSMA, HACCP, GFSI systems, with SQF experience preferred
- Experience with organic regulations and kosher requirements
- Ability to effectively interpret compliance regulations
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers
- Ability to lead and influence cross-functional teams at multiple levels within the organization
- Proven track record of driving continuous improvement and change management skills