This position interprets U.S. Food and Drug Administration (FDA) regulations and provides guidance on how to implement the regulations. Provides guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs. The Food Regulatory Specialist will help evaluate food safety based on FDA regulations (e.g., regulated use limits) and other precedents (e.g., GRAS notices) when FDA regulations do not explicitly cover an Impossible Foods use case.
- Responsible for efforts to ensure compliance with all food safety regulatory requirements.
- Supports and assists the Legal department with preparing regulatory applications to achieve departmental and organizational objectives.
- Acts as a regulatory representative on core product development teams, communicates regulatory requirements, and impact of regulations to the development team. Provides guidance and expertise for packaging material compliance and claim regulations.
- Evaluates IF product formulas and labels when considering international markets where regulations differ.
- Has knowledge of toxicology and experience with GRAS notifications and other food safety evaluations.
- Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.
- Maintains ongoing surveillance and analysis of all pertinent domestic and international regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
- Reviews product labeling and marketing materials for compliance with FDA submissions and applicable regulations.
- Supports the product release process by reviewing and approving requests for product release.
- Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
- Reviews protocols and reports to support regulatory submissions.
- Support all Company initiatives as identified by management and in support of other regulatory requirements.
- Complies with Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- BA or BS degree (degree in a technical discipline highly preferred).
- A minimum of 10 years of technical experience, including at least 5 years of regulatory experience in a food processing industry or biotech.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to communicate effectively at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in a timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 5%, including internationally.
- Ability to maintain regular and predictable attendance.
- Ability to identify and solve problems and work independently with little oversight.