Regulatory Specialist

Company OverviewJamieson Wellness is dedicated to improving the world's health and wellness with its portfolio of innovative natural health brands. Established in 1922, Jamieson is the Company's heritage brand and Canada's #1 consumer health brand. Jamieson Wellness also offers a variety of VMS products under its Youtheory, Progressive, Smart Solutions, Iron Vegan and Precision brands. The Company is a participant of the United Nations Global Compact and adheres to its principles-based approach to responsible business. For more information please visit www.jamiesonwellness.com.Our Jamieson Diversity and Inclusion StatementAt Jamieson Wellness, we cherish diversity, equity and inclusion and we know we must constantly listen, learn and take action to ensure these principles remain embedded in our culture. We encourage everyone to bring their whole selves to work and celebrate the differences that make us unique. We are accountable to build an environment free of bias in regard to citizenship, race, place of origin, ethnic origin, colour, ancestry, disability, age, creed, sex/pregnancy, family status, marital status, sexual orientation, gender orientation, gender identity, gender expression, and all other types of behaviours that are not conducive to an inclusive environment. We hold ourselves and all stakeholders to a high standard of diversity equity and inclusion, because anything else is unacceptable.Overall ResponsibilitiesReporting to the Regulatory Affairs Supervisor (North America), the Regulatory Affairs Specialist (USA) will take the lead in maintaining and submitting all dietary supplement related items to the FDA. The position will support all functional aspects of JWEL’s business for the USA (and work closely with internal departments) including: Quality Control, Quality Assurance, Research and Development, Research Manufacturing, Marketing, Graphics, Supply Chain and Sales to collaboratively interface regulations with current practices. This position requires a dynamic individual able to seamlessly liaise regulatory requirements with internal and external direction.Specific Key Responsibilities & DutiesCo-ordinate the assembly and tracking of Dietary Supplement files including, but not limited to:, label submission creation, allergen review, import and export procedure, general inquiry responses, product review, etc.Working with internal departments to review new raw materials (RMs) and finished products (FGs) or suitable replacements/multiple sources.Review specifications to bring into compliance with regulationsPerform regulatory review of proposed new products/ingredientsMonitor and maintain site license applications for all company divisionsCollect and review, where necessary, scientific documentation from various external sourcesReview labels for compliance of all company divisions for the US marketAssist with international applications as they are applicableService regulatory requirements wherever needed for Nutricorp customers (private label customers)Attend/represent Jamieson at offsite/virtual training related to regulations and report this information back to the rest of the team, where necessary (as appropriate)Maintaining knowledge of changing regulatory environments primarily in USA, but also globally and potential USA impactsConsult and advise functional departments on establishing systems to eliminate regulatory gapsLiaise between government regulators, Jamieson Wellness and its stakeholders.Follows Health & Safety Policies/SOPs including but not limited to the Safety Responsibilities ProcedureWill comply with Good Manufacturing Practices in all GMP sensitive areas of Jamieson Laboratories Ltd. facilitiesOther duties and projects as deemed necessaryKnowledge, Skills & Abilities RequirementsBachelor’s Degree of Science in Nutrition, Food Science, Biomedical Science or an appropriate Life Science from an accredited post-secondary institution3+ years of relevant natural health product/dietary supplement regulatory experienceComprehensive knowledge of USA Dietary Supplements GMP manufacturing operationsWorking knowledge of regulations for other global jurisdictions would be considered an assetAbility to understand and interpret technical and regulatory documentsExcellent written communication skillsStrong organizational and administrative skillsProficient with computers; working knowledge of MS Word, MS Excel, etc. and general ERP systems (such as QAD)Superior demonstrated communication and management skillsHigh degree of resourcefulness, flexibility, adaptability, and problem solving through creative solutionsAbility to obtain results with minimal supervision in a team environmentTeam orientedCommitment to continuous professional improvementOur ValuesACCOUNTABILITY: We do what we say. We take personal ownership for our work and actions and its impact on others and the business.RESPECT: We do it together authentically and inclusively. We actively listen and engage each other, including diverse perspectives.EXCELLENCE: We drive to high standard for product, people and planet. We challenge the status quo and bring forward innovative ideas in the continuous pursuit of quality.AGILITY: We embrace change and act with flexibility. We welcome new ideas and feedback, swiftly incorporating them to improve our performance.How to Apply: All those interested in applying for this job may do so by applying to theHuman Resources by the closing date noted above. All full-time employees who have been in their current position for six months are eligible to post for the said position. Previous work history will be considered in the final section.Jamieson Laboratories Ltd. is an Equal Opportunity Employer and welcomes and encouragesapplications from all interested and qualified candidates. In accordance with the Accessibility forOntarians with Disabilities Act, 2005 and the Ontario Human Rights Code, Jamieson Laboratories Ltd. will provide accommodations throughout the recruitment, selection and/or assessment process toapplicants with disabilities. If selected to participate in the recruitment, selection and/or assessmentprocess, please inform Jamieson Laboratories Ltd. Human Resources staff of the nature of any accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation