Subject Matter Expert: Regulatory Affairs Expert (EU) - Food & Food Ingredients

Remote
Full Time
Experienced
Subject Matter Expert: 
Regulatory Affairs Expert (EU)- Food & Food Ingredients


Reports to: Director, Regulatory Affairs Expert Operations

Summary and Objectives

This position is for a Regulatory Affairs Expert in Food & Food Ingredients
  • The successful Regulatory Affairs Expert candidate will work with internal/ cross functional team members, customers, development teams and stakeholders throughout the organization to ensure client satisfaction in your area of expertise.
  •  You will develop relationships and communicate customer inputs to internal team members and communicate back to customers the schedule of such so that you create a positive client experience.
  • The successful candidate is familiar with fields, concepts, practices, and procedures involved in regulatory compliance generally and Food and Food Ingredient compliance specifically.
  • As Regulatory Affairs Expert, you are the face of the company to its clients in your area of expertise. You are expected to have or acquire deep expertise in all aspects of your subject matter and/or related product modules.
  • SMEs have primary responsibility for ensuring that content provided to clients in their subject matter area across all products is current, accurate and provides sufficient added value.
  • You will identify and attend industry meetings, speak at conferences where possible, continually build deeper expertise and become known in the industry as an expert in their field and use these meetings to build deeper relationships with clients.
  • Experience in USDA regulation, food labelling and claims.

Responsibilities as Regulatory Affairs Expert-Food and Food Ingredients
  1. Assure Scope and Currency of Regulatory Content
  • Cornerstone to our business model is the currency, completeness, and user friendliness of our data. You are ultimately responsible for all areas of subject matter coverage across all products and services.
  • Identify/fix gaps or weaknesses in coverage.  If in your space, you must see that gaps or weaknesses get fixed.  This may mean working with internal resources in IT, sales, etc. to resolve areas of improvement.
  • Establish, control over and maintain the audit process for data and timely updating of your modules.
  1. Client Interaction
  • Nothing replaces direct contact with clients.  It is imperative that you build trusting relationships with as many clients as possible in your subject matter area. Introducing other team members to those clients as well.
  • Interact with Business Development to foster growth at both existing and new clients.
  • Communicate and develop potential areas of opportunity with the business development team.
  • Each Regulatory Affairs Expert should act as key account manager for at least 1-2 Top 25 clients.
  • Answer questions and coordinate with country researchers or other staff who are best able to answer questions.  Answers to substantive questions should generally come from you, though in limited cases especially with difficult languages, having the senior regulatory researcher answer may be appropriate. Acknowledge client issues quickly and inform the client even if the issues will take time to resolve.
  • If no one on staff can answer, contact governments directly to ascertain correct answers.  If no response from governments, escalate to management to reach out to the government via diplomatic channels.
  • Train clients in an interactive way on our tools as the single best way to learn their needs.
  • Measure and report response times with the goal to continually improve response time and client satisfaction.
  1. Assist in Product Development
  • A deep understanding of our products is critical to the success of the position.  You should be able to use and explain your module better than anyone else at the company.
  • Focus at all times on assuring consistency within and across products.
  • Coordinate with Research, Data, Systems and Consulting Teams to ensure continued growth and improvement of our products.
  • Know and document the country hierarchy, if applicable, for your module; work with Research to confirm documentation; and be able to defend every decision when we pull in other jurisdictions by incorporation.  (e.g., 1. Germany, 2 European Union)
  • Be aware of emerging concerns in your area of expertise and communicate those to the team.
  • Disseminate information learned at conferences, client meetings, etc.
  • Our clients are usually experts in their space.  Collaborate with and learn from them to grow our “real life” understanding of how certain types of issues and products are managed.
  • Enter and reply to JIRA tickets for your module to ensure corrections and updates are made regularly and also to support client needs.
  • Attend weekly internal calls as available and contribute to related agenda, action items, etc.
  1. Involvement in Regulatory Consulting Projects
  • The Regulatory Affairs Expert will be involved with regulatory consulting projects of varying types.
  • Assure timely and accurate completion of projects.
  • Identify additional external short-term resources available for projects in your space.
  • Track hours according to established internal procedures and submit as directed.
Qualifications:
  • Previous hands on regulatory experience in industry or preferably in the Food and Food Ingredients with accomplishments including labelling/artwork and formulation review, regulatory product compliance and ideally across a number of global regions with EU as essential and US Canada or other countries as desirable and the primary tier.
  • Established and continued development in core competencies:
    • Deep and continual growth of knowledge in your subject matter expertise as well as in management.
    • Excellent written and spoken communication skills and interpersonal skills.
    • Ability to communicate with customers and teams professionally.
    • Good time management skills and ability to provide on time delivery of consulting outputs.
    • Demonstrated ability to work well with cross-functional teams located around the globe (for example with data teams, technology teams, management teams, subject matter experts).
    • Proficient in written and spoken English. (Proficiency in other languages a plus).
  • Solid organizational skills including attention to detail

Overall Requirements
  • Up to 10% travel may be necessary.
  • Ability to work as part of a team, as well as independently.
  • Report to management once per month on status, issues and personnel needs
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