To strengthen our regulatory affairs division for USA activities, we seek a Regulatory Affairs Consultant with experience working on food and nutritional products in the USA.
You will have experience in regulatory affairs with demonstrated experience working on a range of food products (food supplements / dietary supplements, general foods, foods for special medical purposes, and novel foods / GRAS dossiers).
Experience in EU and UK regulatory affairs is not essential but would be beneficial.
Carrying out formula and label reviews for food and nutritional products including food supplements / dietary supplements according to the applicable USA regulations. Examples of ingredients include vitamins, minerals, botanicals, solvents, additives, excipients, natural extracts, etc.
Making recommendations on how to alter product formulations to be compliant in the USA taking into account the business and scientific objectives.
Review health claims and structure-function claims according to FDA guidance; research and compile claim substantiation dossiers.
Advising on all regulatory and quality questions relating to food supplements / dietary supplements, novel foods / novel ingredients (NDIN and GRAS), general foods and medical foods.
Identify and interpret relevant regulatory guidelines.
Drafting regulatory framework documents.
Assisting in regulatory submissions in the USA.
Coordination of laboratory testing.
Attend client calls to present work and answer questions.
Degree in human nutrition, food science, or similar.
Experience with USA (and EU/UK) food regulations
Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel
Ability to work independently with minimal supervision, and as part of a team
Desired qualities: autonomy, flexibility, communication, technical writing, team mindset
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.