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Regulatory Affairs Specialist

Total Life Changes LLC Fair Haven, MI

  • Posted: over a month ago
  • Full-Time
Job Description

Position Details:

Title: Regulatory Affairs Specialist 

Department: Supply Chain

Location: TLCHQ  

Reports To: Global Supply Chain Manager

Position Summary:

We are looking for a Regulatory Affairs Specialist to join our team. The ideal candidate will work as an internal and external liaison to implement all regulatory and legal activities in accordance with TLC procedures and regulatory requirements within the scope of Supply Chain and legal departments.

Position Duties and Responsibilities:

  • Demonstrate strong knowledge of relevant regional and national regulations, including but not limited to health claims, labeling, ingredient acceptability, classification, and product registration / notification / certification and import requirements for countries of responsibility
  • Completes compliance review of new concept formulas to determine ingredient acceptability, product classification, allowable claims, and potential sales restrictions for countries of responsibility
  • Review’s product packaging content (e.g., labels, cartons, inserts, pouches, etc.) for compliance with national laws
  • Keeps company up to date on regulatory changes for assigned markets of responsibility
  • Understand the regulatory landscape of the company's North American markets and create strategies which will ensure that the planning and execution of each regulatory filing is managed effectively and efficiently, on schedule and within budget
  • Work directly with regulatory contacts in all markets, including company personnel, legal counsel, regulatory consultants, and government agencies to register/notice the company’s products and comply with applicable regulations and laws
  • Work closely with Research and Development, Quality Assurance and Purchasing organizations to obtain the documents required to register/notice the company's products, to include product testing, product safety, manufacturing processes, labelling and product claim substantiation
  • Ensure that marketing materials are compliant in relevant markets and maintain/manage documentation files
  • Coordinate with Project Managers regarding regulatory timelines and risks.
  • Have a working knowledge of relevant product laws and regulations

 

 

Position Skills, Education and Experience required:

  • Ability to work flexible hours
  • Superior communication skills in verbal and written form. Advanced presentation skills
  • Ability to effectively interact with all levels of employees
  • Ability to explain complex concepts to non-technical audiences
  • Advanced problem solving/trouble shooting skills
  • In depth understanding of a production / manufacturing environment
  • Advanced proficiency in Microsoft Excel, PowerPoint, and Word
  • Bachelor’s Degree in Microbiology, Chemistry, Biochemistry, Food Science, or related field
  • Experience in food products, manufacturing processes and environments is preferred. Including cGMP and FSMA 
  • International regulations experience a plus
  • Minimum one year experience in regulatory affairs or quality assurance desired, with a preferred emphasis in dietary supplements or pharmaceutical products; other Direct Selling industry experience will also be considered

Total Life Changes LLC

Address

Fair Haven, MI
48023 USA

Industry

Government

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