About the job

To strengthen our Nutrition Teams, RNI (a ProductLife Group Company) is urgently looking for a Regulatory Affairs Consultant with experience working on nutrition & health products for the US market.

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Responsibilities

The candidate will have 5+ years’ experience in regulatory affairs with demonstrated experience working on a range of nutritional products (common general foods, dietary supplements, infant food/baby formula, medical food) on the US market.

Experience in other industries will also be beneficial as you could also be working on self-care medical devices, cosmetics, herbal medicines, biocides and borderline products.

Your responsibilities will include:

  • Carrying out formula and label reviews for nutritional products including general foods, food supplements, infant formula/baby food and medical foods according to the applicable US Regulations. Examples of ingredients include vitamins, minerals, botanicals, solvents, additives, excipients, natural extracts, etc.
  • Making recommendations and advising clients on how to alter product formulations and labels to be compliant in the US considering the business and scientific objective of our clients.
  • Reviewing health and nutrition 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.
  • Develop regulatory strategies for market access for a large range of nutritional and health products.
  • Identify and interpret relevant regulatory guidelines.
  • Drafting regulatory framework documents.
  • Assisting in regulatory submissions in the US.
  • Attend client calls to present work and answer questions.

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Education

  • At least a Bachelor’s Degree in human nutrition, food science, food law or similar.

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Experience

  • At least 5 years’ experience in regulatory affairs working on a range of nutritional products (common general foods, food/dietary supplements, infant formula/baby food, medical food) on the US market.
  • Experience with European, Canadian or other international food regulations would be an advantage.

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Skills

Hard/Technical skills:

  • Knowledge of US food regulations is required
  • Knowledge of the US importation process for products from foreign manufacturers (FSMA, Prior notice, FSVP et PCQI).
  • Good IT skills/knowledge including proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel.
  • Knowledge of regulations regarding self-care medical devices, cosmetics, herbal medicines, biocides and borderline products is ideal but not mandatory

 

Soft skills:

  • Fluent English is required
  • Excellent organizational and interpersonal skills
  • Excellent oral and written communication skills, including facing the client
  • Ability to work independently and autonomously with minimal supervision, and as part of a team.
  • Ability to prioritize different workloads/multi-task
  • Ability to deliver on tight timelines
  • Personal responsibility for ensuring a high standard of work

Regulatory Affairs Consultant for Nutrition and Health Products M/F - 127

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