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Regulatory Affairs Specialist

Location
Peterborough, ON
Job Type
Full-time

Noblegen Inc. is an advanced bioproducts manufacturer dedicated to developing cost-effective, naturally-derived biomaterials and biochemicals for a wide range of consumer and industry sectors. Our platform allows for the development of cost-effective dietary, health and biochemical products. These products are inspired by a clear and simple vision – to make a meaningful difference by delivering biologically inspired solutions for some of the world’s greatest problems. Nature is the foundation for our products.

REGULATORY AFFAIRS SPECIALIST

Responsibilities:

This position would report to the Manager of Product and Market Development. The primary responsibility of this position is to collaborate with the internal and external team to develop and execute Noblegen’s regulatory strategy, ensuring compliance to all regulations, standards and guidelines. The individual in this position must have a significant understanding of regulatory processes across regional jurisdictions for human nutrition.

Areas of responsibility include:

  • Project management
  • Effective interpretation, application and clear communication of U.S., European and Canadian food regulations guidelines and policies to clients and fellow team members is a must
  • Some administrative tasks that include maintaining project files and archiving
  • Staying up to date on food regulations pertaining to job function via mailing lists, journals, FDA, EFSA, CFIA websites, attending webinars
  • Assist in preparing all necessary documents and materials for high quality and timely filings of Noblegen’s dietary ingredients
  • Prepare filings to strict deadlines
  • Monitor filings to anticipate challenges and respond to feedback from external regulatory team
  • Assist in reviewing regulatory assessment of changes for impact to marketed ingredients
  • Assist in maintaining statistics associated with actual government review times and other relevant details for similar ingredients in a variety of jurisdictions
  • Build, develop and maintain interactions with Authorities and other external stakeholders through effective collaboration and communication
  • Request and assist in conducting Authority meetings as needed during filing process
  • Partner with internal departments such as Legal, Quality Assurance, Product and Market Development, etc. on relevant regulatory activities and strategies to support company products
  • Interact with management and negotiation teams
  • Assist in regulatory inspections and develop presentations to regulatory authorities and other stakeholders
  • Review promotional material and regulatory labeling for regulatory requirements, as required

Qualifications:

  • Minimum of a Bachelor's degree in Nutrition, Food Science or related discipline (Master's preferred)
  • Knowledge of U.S., European and Canadian Regulations will be an asset
  • Proficient computer skills, including all MS Office applications
  • Proven oral and written communication skills
  • Ability to build and maintain strong and collaborative working relationships with internal and external contacts
  • Strong organizational and negotiation skills
  • Ability to work independently and under pressure

If you have great communication skills, a keen eye for detail, and the ability to adapt, we want you on our team.

Current openings

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