Senior Regulatory Specialist

Playa Vista, CA • 11-14-2017
Irwin Naturals is a nutritional supplement company seeking an individual to fill their Senior Regulatory Affairs Specialist to provide regulatory and quality assurance support for dietary supplements and healthy food brands. This role 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.

Main Duties:
  • Provide domestic and international regulatory guidance on product development and product label creation.
  • Assist in the negotiation of technical issues with external entities including contract manufacturers, health authorities and domestic regulatory agencies. 
  • Communicate with regulatory agencies on administrative and routine matters.
  • Perform detail review of product formulas to ensure accuracy of raw material ingredients.
  • Manage Canadian Product Licensing and foreign registration processes.
  • Manage 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 Engineering Change Order program.
  • Obtain GMP Declaration, Free Sale Certificates and Country specific Declarations.
  • Assist with acquiring necessary State and Federal regulatory licenses as needed.
  • Maintain external references, lists of national and international regulation 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 technical database.
  • BS in Scientific discipline such as Biology or Chemistry or Food Science, Master’s Degree in Scientific discipline is preferred.
  • 1 -2 years of experience in research and development involving new formulations.
  • 3 - 4 years direct experience in regulatory affairs or compliance (focus on U.S., Canadian regulations).
  • Experience in registering products in Canada and Mexico. 
  • Must be knowledgeable of labeling and quality regulations for dietary supplements (food experience a plus).
  • Must have experience with document control and engineering change orders.
  • Must have experience with researching scientific literature as well as specific industry regulations (21 CRF 101.9 and .36). 
  • Must have experience preparing Excel spreadsheets.
  • Experience in dietary supplement manufacturing environment preferred.
  • Experience with managing projects of different complexities.
  • Experience with Genesis software.
  • Experience performing scientific substantiation review preferred.
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