Regulatory Affairs Specialist

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Job Description

Position Summary:


Regulatory Affairs Specialist will be responsible for providing regulatory guidance, document control, and product label review support to various areas of the company including Product Development, Marketing, Sales, Graphics, Operations, and Legal.                        


Key Activities:


  • Provide domestic and international regulatory guidance on product development and product label creation.
  • Communicate with regulatory agencies on administrative and routine matters.
  • Perform detail technical review of product formulas to ensure the accuracy of raw material ingredients.
  • Perform complex chemical calculations to ensure the strength and potency of ingredients are at the correct amount in formula.
  • Review technical data and perform nutritional calculations ensuring that nutritional information on supplement facts and nutritional facts panels are accurate.
  • Applying expertise in regards to product labeling, food allergens, genetically modified foods, nutrition, organic and religious suitability (Kosher/Halal), FEMA GRAS, FDA, USDA and international laws that govern the safety of flavorings/food ingredients.
  • Perform scientific statistical analysis on formulation analytical data.
  • Manage Domestic and International registration projects as needed by customers.
  • Develop Formula Specifications and Supplement Facts in collaboration with Product Development, Marketing, Contract Manufacturers, and Quality Assurance departments.
  • Review and approve final product packaging based on compliance with U.S. labeling regulations.
  • Assist with management of the Engineering Change Order program.
  • Maintain external references, lists of national and international regulatory standards, and FDA guidance documents that affect the products and operations.
  • Provide technical assistance on various department tasks and projects as needed.
  • Assist with writing and reviewing department standard operating procedures.
  • Assist with managing document control activities within the department.
  • Assist with acquiring technical data and information from contract manufacturers and maintain a technical database.


Required Qualification:


  • BS in a Scientific discipline such as Biology or Chemistry or Food Science.
  • 3 years of direct experience in regulatory affairs or compliance within the flavors, chemicals, ingredients, food, and beverage industry.
  • Must be knowledgeable of U.S. labeling and quality regulations for flavor industry.
  • Must have experience with document control and engineering change orders.
  • Must have experience with researching scientific literature as well as specific industry regulations.
  • Must have the ability for continuous learning, comprehension and application of scientific data and demonstrate sense of urgency and deliver worry free service to our customers.
  • Experience with managing projects of different complexities.

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Posted: Sep 24, 2020

Type: Full Time

Category: Regulatory Affairs