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Regulatory Affairs Specialist - EMEA

Date: Feb 16, 2019

Location: Dublin, D, IE

Company: Glanbia

Position Title: Regulatory Affairs Specialist - EMEA

Reporting to: Regulatory Affairs Manager - EMEA            

Department / Function/Business Unit: Legal and Regulatory


Job Purpose:  

Support EMEA product commercialization for Glanbia Performance Nutrition (GPN) brands such as ON, BSN, Nutramino, Isopure, and Amazing Grass; as well as the contract business for all activities involving regulatory compliance from concept to launch.


Principal Accountabilities (not definitive)

  • Work closely with Branded and Contract R&D Department to review formulas and Raw Material Specifications required for the development of Product Specification Sheets.
  • Create technical Product Specification Sheets for GPN EMEA Innovation (Branded Innovation, Product Enhancements and Line Extensions) from NPD Formulations
  • Create technical Product Specification Sheets for EMEA Contract Development from Formulation Information. Complete individualised specification documents for contract customers.
  • Creation and management of Label Specification Sheets (collaborating technical and marketing information) for GPN Innovation (Branded Innovation, Product Enhancements and Line Extensions).
  • Review and approve artwork on the electronic proofing system (Proof HQ) making sure that they match the approved Label Specification Sheet.
  • Create product certificates to support the sales and commercial team for new product launches.
  • Provide appropriate documentation for product notification/registration where necessary.
  • Advise on nutrition & health claims to be used on labels and on marketing material.
  • Conduct regulatory reviews of current GPN Labels/Websites and recommend changes.
  • Stay abreast of changes to the EU regulatory environment, and communicate internally to relevant departments.   


Key Challenges & Success Measures

  • Supporting the launch of compliant branded and contract products according to project timelines.
  • Timely and accurate product specifications & label spec sheets.
  • Timely label reviews with attention to detail, ensuring all compliance issues are considered.
  • Accurate, risk-based approach to regulatory queries.


Skills, Know How and Experience:

  • Must be organized, thorough and detail oriented. 
  • Extensive software skills a plus, as well as internet research abilities
  • Strong communication skills.
  • Able to work independently but also must be a strong team player liaising with many cross-functional teams
  • Ability to work to tight deadlines.


Education Requirements:

  • Bachelor Degree in Nutrition, Food Science, Biology or related discipline.
  • At least 1 year experience with Labelling of  Food Supplements and Food.
  • Knowledge of harmonised EU food legislation.
  • Knowledge of national food legislation a plus.


Language Requirements: 

  • Must be able to read and write proficiently. 
  • Knowledge of a second European language a plus.


Computer Skill Requirements: 

  • Must be proficient in Microsoft Office (Word, Excel, PowerPoint, Office).