Food Science Job Types - Regulatory Affairs Positions

What is a Regulatory Affairs Specialist?

A regulatory affairs specialist is a scientist, usually housed in the quality assurance department, who develops and executes regulatory assessments to ensure successful registration and approval of nutritional products. He/she works with local and federal government agencies in the US and, depending on the position, with Health Canada and agencies outside the US. For example, if a new product has been developed by the R&D department, that product must be approved by USDA or FDA and other local agencies before it can be put on the shelves. The label on the package must be exact, and the specifications of all of the ingredients must be submitted for approval. The regulatory specialist identifies and obtains the documents needed, and ensures that they are effectively presented for the registration of the products. He/she is the one who maintains awareness of new regulatory legislation and assesses the impact on the business and product development programs.  He/she reviews and maintains all of the regulatory documents, including labels, promotional materials, manufacturing change requests, and registration packages.

Depending on the level of the position, this individual might travel to meetings with the FDA or USDA. A more senior level person generally is the personal contact with the government agencies. He/she would advise their company on international regulatory requirements. They would assist in the development of regulatory strategy and update strategy based on regulatory changes. He/she usually functions independently, but participates and contributes to decisions in cross functional team meetings.

What are the  qualifications?

A BS or MS in food science, nutrition, or other scientific degrees are preferred. This is a very detail oriented position so excellent organizational skills are a must. Superior time management skills is also critical for this role. Most candidates have worked in a quality assurance or research and development role first before they go into regulatory affairs. Although there are very few courses that an undergrad can take, Michigan State offers a program in regulatory affairs, where a MS degree can be obtained.

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