Regulatory Affairs Specialist (Ingredient Compliance)

Job Description

About Quality Smart Solutions

Quality Smart Solutions Inc. is a science and compliance consulting firm globally serving consumer health product companies in Natural Health Products, Dietary Supplements, Foods, Cosmetics, Over- The-Counter DIN products, Medical Devices, Cannabis, and Ingredient regulatory and quality areas.

Our timely, cost effective, solutions-oriented approach has ensured client satisfaction and has established Quality Smart Solutions as the preferred partner in science and compliance.

Job Description:

The Regulatory Solutions Specialist (Ingredient Compliance) will lead and guide our clients on matters related to regulatory toxicology and compliance for ingredient compliance related projects (GRAS, EFSA, Health Canada, UK FSA). This role includes both client-facing responsibilities along with dossier preparation. The position is a full-time, remote-based position working with a team of full-time staff and subcontractors.

Responsibilities:

Prepare detailed technical dossiers for toxicological safety/risk assessments of ingredients and other substances across various jurisdictions

Support substantiation of food and supplement health claims through in-depth analysis of scientific research by conducting systematic literature searches, quality appraisals, and summaries of clinical trials

Work with clients and internal team to support the preparation and development of Self-Affirmed GRAS, EFSA novel food, Health Canada novel food, food additives and feed additives, ingredient NPNs,

Conduct research to derive dietary intake values, and summarize historic safety data, for novel ingredients and substances.

Liaise with our internal teams and client to ensure projects move forward in an efficient manner.

Engage with government agencies to address any concerns or abstract client inquiries for projects.

Assist in recruitment of GRAS expert panel members, where applicable

Take into account business needs of clients in strategizing regulatory options

Participate in our company social media campaign and write/prepare blogs on various regulatory topics

Experience/Skills/Education qualifications:

Undergraduate university degree in Science or Diploma/ Post Graduate certificate in Regulatory Affairs from a Canadian accredited school

1-7 years' experience in a consulting or toxicological environment. Experience in a consulting firm environment an asset

FDA contacts an asset

FDA GRAS dossier technical writing and/or submission of GRAS dossier to FDA mandatory

Experience with FEMA GRAS an asset.

Experience with FDA deficiency letters an asset

Experience with Health Canada, EFSA, FSA (UK) and/or Australia novel food and food additive submissions an asset

Experience with infant formula and medical food submissions an asset

Ability to perform literature and information searches with such online databases as PubMed, Cochrane, Google Scholar, NMCD

Fluent in English writing, reading and speaking a requirement.

Computer skills in internet search engines, Microsoft Word, Excel

Excellent verbal and written and grammatical skills

Well versed in medical and regulatory terminology

Excellent problem recognition and resolutions skills

Can quickly learn new regulations and applications procedures as per client requests

Ability to work independently with little supervision

Ability to work in a fast-paced entrepreneurial environment

Ability to handle multiple projects and meet deadlines and client deliverables

Attention to detail and high level of accuracy

Experience in international regulatory affairs an asset (USA, UK, EU, South America in particular)

Quality Smart Solutions is an equal opportunity employer.

Please email your resume to with the Subject title: Regulatory Solutions Specialist (Ingredient Compliance) role