Health Regulatory Affairs Specialist m/w
19 hours ago
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.
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). The position is a full-time, remote-based position working with a team of full-time staff and subcontractors.
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.
· 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
Undergraduate university degree in Science or Diploma/ Post Graduate certificate in Regulatory Affairs from a Canadian accredited school
· 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
· Well versed in medical and regulatory terminology
· Ability to work independently with little supervision
· Ability to handle multiple projects and meet deadlines and client deliverables
· Experience in international regulatory affairs an asset (USA, UK, EU, South America in particular)
Quality Smart Solutions is an equal opportunity employer.
Regulatory Solutions Specialist (Ingredient Compliance) role
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