Regulatory Specialist

4 weeks ago

Windsor, Canada Jamieson Wellness Inc. Full time

Company Overview

Jamieson 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 Statement

At 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 Responsibilities

Reporting 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 & Duties

  • Co-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 regulations
  • Perform regulatory review of proposed new products/ingredients
  • Monitor and maintain site license applications for all company divisions
  • Collect and review, where necessary, scientific documentation from various external sources
  • Review labels for compliance of all company divisions for the US market
  • Assist with international applications as they are applicable
  • Service 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 impacts
  • Consult and advise functional departments on establishing systems to eliminate regulatory gaps
  • Liaise between government regulators, Jamieson Wellness and its stakeholders.
  • Follows Health & Safety Policies/SOPs including but not limited to the Safety Responsibilities Procedure
  • Will comply with Good Manufacturing Practices in all GMP sensitive areas of Jamieson Laboratories Ltd. facilities
  • Other duties and projects as deemed necessary

Knowledge, Skills & Abilities Requirements

  • Bachelor’s Degree of Science in Nutrition, Food Science, Biomedical Science or an appropriate Life Science from an accredited post-secondary institution
  • 3+ years of relevant natural health product/dietary supplement regulatory experience
  • Comprehensive knowledge of USA Dietary Supplements GMP manufacturing operations
  • Working knowledge of regulations for other global jurisdictions would be considered an asset
  • Ability to understand and interpret technical and regulatory documents
  • Excellent written communication skills
  • Strong organizational and administrative skills
  • Proficient with computers; working knowledge of MS Word, MS Excel, etc. and general ERP systems (such as QAD)
  • Superior demonstrated communication and management skills
  • High degree of resourcefulness, flexibility, adaptability, and problem solving through creative solutions
  • Ability to obtain results with minimal supervision in a team environment
  • Team oriented
  • Commitment to continuous professional improvement


Our Values


ACCOUNTABILITY: 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 the

Human 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 encourages

applications from all interested and qualified candidates. In accordance with the Accessibility for

Ontarians 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

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