Regulatory Affairs – USA
Permanent On-site | Windsor, ON
Description
Responsibilities:
- 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 customers (private label customers)
- Attend/represent company 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, organization 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 facilities
- Other duties and projects as deemed necessary
Qualifications
- 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
- 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
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