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Manager, Regulatory Affairs - U.S.

Manager, Regulatory Affairs - U.S.

Requisition ID 
2017-2639
Job Locations 
US-IL-Westchester
Job Family 
Legal (LG)

More information about this job

Responsibilities

Position Location: Westchester

Business Unit:    North America Quality Control

Reports To:         Sr. Manager, Quality & Regulatory Affairs - U.S. / CA

 

Primary Function

Develop, improve and direct the implementation of Regional Regulatory Standards and Systems applied at US manufacturing plants to ensure compliance with Company policies and standards, government regulations and customer requirements. This function leads the efforts to maintain regulatory compliance for current ingredients, including sweeteners and ingredient specialties. This person should be experienced in interpreting regulations and implementing sound guidance and company policy to comply with applicable regulations in the United States.

 

Key Deliverables             

Business             

  • Monitor, interpret and advise business teams on relevant changes in United States that impact our product lines.
  • Interpret regulations and implement sound guidance and company policy to comply with applicable regulations.
  • Advise on issues including: package labeling and common name, product safety and risk assessment analysis, product and package label claims and claim support.
  • Manage and maintain customer regulatory compliance documentation files; product safety data sheets, raw material and finished product toxicology information, regulatory approval submissions, and relevant regulatory compliance documentation.
  • Oversee preparation and timely customer delivery of selected regulatory compliance documentation (customer questionnaires, surveys, letters of guarantee) in coordination with the Quality Document Management team.
  • Engage with and provide regulatory guidance to Quality teams as it relates to US manufactured products and those imported into the US for sale.
  • US regulatory compliance review for existing products in NPI
  • Administer compliance requirements of the EPA Toxic Substances Control Act (TSCA)and Food Contact Notifications (FCN)
  • Maintain working knowledge of national chemical control laws (CEPA, EINECS, MITI)
  • Administer compliance requirements of FDA Drug Master Files.
  • Maintain GHS compliant safety data sheets – work towards harmonizing SDS systems between NS Legacy and CPC Legacy
  • Provide regulatory support to Trade Compliance as needed
  • Review and approve any changes to existing raw materials
  • Assign HTS Classification for new product
  • Assure facility registration and re-registration for processing sites in the United States

 

Agility and Innovation

  • Creates robust processes and systems to enable continuous improvement of the regulatory affairs function
  • Conduct United States regulatory compliance review for modifications of current product lines in the New Product Introduction (NPI Lite) process and support new systems for Product Lifecycle Management (PLM)
  • Review all supplier documentation for accuracy and verify regulatory references.
  • Maintain food bioterrorism registrations and drug establishment registrations for US based operations.

Relationships and People            

  • Interact with governmental regulatory agencies, when necessary
  • Key contacts within this role
  • Product Assurance and Regulatory Affairs
  • US marketing, sales and technical members
  • International Compliance
  • Ingredion functional support groups such as Legal, Global Research & Technology, Global Process Technology, Document Management, Quality, Quality, Measurement and Analytical Services, Government and Environmental Affairs, Open Innovation, & Sensory Science
  • Trade and scientific associations, such as Corn Refiners Association, Calorie Control Council, International Stevia Council, & Council for Responsible Nutrition
  • External scientific, regulatory and toxicology consultants

 Knowledge, Skills, and Requirements:    

  • BS in a scientific discipline such as Chemistry, Food Science, Cereal Science, Toxicology, or Regulatory Affairs. MS in a related field is preferred.
  • 5-8 years of U.S. food, personal care and/or industrial regulatory compliance experience; international food regulatory experience a plus
  • Team and business leadership experience and skill
  • Record of accomplishment in this field
  • Effective oral and written communicator, strong listening skills
  • Demonstrated project management skills      

Desired behavior, personal attributes:   

  • High degree of integrity and standards
  • Attitude and ability to work in a team environment
  • Multi-cultural/international awareness and sensitivity
  • Forms and values strong interpersonal relationships
  • Focused on partnering with customers, and internal business units to achieve or exceed strategic goals
  • Sets, prioritizes and enables achievement of ambitious goals

Relocation Available:      YES – Relocation Within Country Considered

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