Regulatory Affairs Consultant for Nutrition and Health Products M/F

4 weeks ago

Port Chester, United States CareerBuilder Full time

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

Europe, USA
-
-
Regulatory Affairs
Permanent contract
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.
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.
Education

At least a Bachelors Degree in human nutrition, food science, food law or similar.
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.
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
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

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