Senior Regulatory Affairs Manager

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Senior Regulatory Affairs Manager
The candidate is a key member of the Regulatory Affairs team and will lead the daily regulatory operations and compliance for the company. Will lead and guide the company to determine and adhere to essential meat and food compliance regulations, guidance, and applicable statute. Will serve as the subject matter expert for the company for both FDA and USDA regulatory compliance determinations, proactive assembly of appropriate federal, state, and local documentation to establish safety for all company products and product lines, as well as ensuring compliance with company partners in production, including ensuring regulatory clarity for longterm key innovation priorities. Establish daily and long-term, proactive regulatory FDA and USDA pathway and compliance policies and procedures for research, development, and commercial scale activities. Establish and maintain regulatory relationships internal to the company and with key community and government stakeholders at the federal, state, and local San Francisco Bay Area level to promote Company mission and values in the form of appropriate compliance and communication. Collaborate with the Company leadership to support the public policy and government affairs team to create consistent and cohesive policy positions on a host of issues that affect the Company including public safety, sustainability, packaging, food, meat food, and seafood regulation. Excellent knowledge of and experience with FDA and USDA regulations, guidance, and applicable statute. Strong track record of regulatory success bringing novel food and/or agricultural products to market and integration with a quality management team. Established network of contacts within the industry that includes trade associations, consultants and regulatory agency contacts that can be accessed and used to identify and resolve regulatory issues, including California state authorities. Extensive experience with and understanding of regulations, regulatory processes, as well as understanding of how federal and state regulatory agencies interpret and apply the regulations. Excellent writing and communication skills for both internal and public audiences. Effective organizational and planning skills to apply daily in a multidisciplinary and matrixed environment. Willingness to collaborate with Quality Management, Scaled Production, and Research teams to understand unique regulatory needs of Company. B.S., M.S., Ph.D., or JD in regulatory science, regulatory law or risk assessment, cellular or molecular biology, meat science, fermentation science, or applicable industry experience in related areas. 5-10 years of experience working in the regulatory sciences within the food manufacturing industry. Experience preferable in processed fresh and frozen meat products in both ready to eat and ready to cook categories with various protein species: beef, pork, poultry and seafood. Familiarity with industrial fermentation systems. Deep subject matter expertise in current Good Manufacturing Practices and FDA food safety frameworks. Demonstrable success in designing and implementing evidence-based risk assessment frameworks for food production and safety establishment. Former federal or state food regulatory employment desired. Extensive experience in sourcing and applying legal, regulatory, and policy precedents to novel food products. Demonstrable success in assembling federal safety dossiers for food products, procuring grants of inspection, and USDA pre-market label approvals.

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