Join Our Team at Quality Smart Solutions

Position Summary  

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. 
 

Detailed 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 

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 

• 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) 

Our Perks:  

We’re looking for exceptional skills and experience because we offer competitive compensation and benefits, including:  

• Competitive compensation structure.  

• Opportunities for meaningful personal and professional growth, where your unique background and experience are valued.  

• Fast-paced work environment that fosters continuous learning and development.  

• Clear opportunities for career growth and advancement. 

Equal Opportunity Employment

Quality Smart Solutions is an equal opportunity employer. Please email your resume to careers@qualitysmartsolutions.com with the Subject title: Regulatory Solutions Specialist (Ingredient Compliance) role.