Regulatory Affairs Consultant

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.

The candidate will have 5+ years’ 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 mandatory but is preferred as well. In addition, experience in other industries will be a bonus but not mandatory (e.g., cosmetics, medical devices, OTC products, biocides etc…).

 

About us

Group 10
Responsibilities

 

  • 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.

Additional Skills

  • 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

Regulatory Affairs Consultant