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Director, Regulatory Affairs

Date: Jun 19, 2021

Location: Downers Grove, IL, US, 60515

Company: Glanbia

Job Title:       Director Regulatory Affairs, International                                

 

Location:  Downers Grove, IL

 

General Summary: The Director of Regulatory Affairs, International will be an experienced regulatory professional whose primary responsibilities will be to provide regulatory and compliance advice on all EFSA, Middle East, Asian and related international regulatory compliance matters.  This position would not have responsibility for regulatory compliance in the Americas. The Director of Regulatory Affairs, International will be an integral part of a 13-person department, will lead  a team of 5-7 non-lawyer regulatory specialists, will report directly to GPN’s Managing Counsel Regulatory Affairs, Julie Wagner, and will interact directly with Glanbia Performance Nutrition’s product development, operational and commercial teams.

 

 

Essential Functions:

  • Oversee all International regulatory and compliance matters to ensure appropriate practicesfor a diverse corporation with significant international growth.
  • Oversee the compliance aspects of all EFSA, Middle East, Asian and other international regulatory authority related matters.
  • Interface regularly with the Managing Counsel Regulatory Affairs, executive team, external/internal clients, and business partners.
  • Keep senior management informed by determining governmental affairs needs, and producing compliance bulletins on legislative and regulatory changes.
  • Ensure all products, labels and advertising materials comply with all applicable laws and regulations in the relevant international markets.
  • Develop, implement, and manage a strategic compliance plan in support of business objectives, including the budgeting for and managing of external international regulatory consultants.
  • Provide practical, pragmatic guidance and recommendations on new product formulations, labels, and usage claims to innovation teams to assure compliance with applicable international laws and regulations;
  • Represent the company and participate in industry-related regulatory committees on its behalf;
  • Support international and contract manufacturing customers with documentation needed to register products in local markets and/or obtain listings with key customers; and
  • Lead, develop and supervise a team of 5-7 non-lawyer regulatory specialists.

 

Knowledge, Skills and Abilities: 

  • Experience developing and managing others required.
  • Proven track record providing regulatory guidance, compliance analysis and leadership in or to the functional food and/or food supplement industry;
  • Extensive regulatory background pertaining to the manufacture and sale of functional foods and/or dietary and nutritional/food supplements for international markets; and
  • In-depth knowledge of EU regulations applicable to functional foods and food supplements; and working knowledge of applicable Middle East, Asian and  other similar international regulations.
  • Knowledge of food & nutrition sciences; BA/BS, MS or PhD degree in science is strongly preferred;

     

Education/Experience:

  • 10+ years’ regulatory and related compliance experience in or supporting the functional food and/or food supplement industry with extensive knowledge of laws and regulations pertaining to the manufacture and sale of nutritional supplements for international markets
  • Experience managing a global team
  • Excellent educational credentials are required
  • In-house experience at a major company is preferred, as is an undergraduate or advanced degree in science


Nearest Major Market: Chicago