Our client is a company that helps people change their lives by reclaiming their health, wellness and confidence. Their success starts with the people who work for them. Their employees are talented, inspired and driven. The policy of our client is to reward performance and hard work. The environment is fast paced and exciting! Located in the Northeast, they are seeking to find a technically strong and energetic Regulatory Affairs Manager.

Position Summary:

This position will apply/develop knowledge of food and nutrition.

1) assure compliance of product formulas, labels and communications,

2) contribute to and advise innovation and renovation projects, and

3) understand the impact of regulatory proposals and changes, through participation in internal cross-functional teams and contributing to industry working groups in order to advise the business. This position will set and manage the regulatory approval of labeling artwork, product claims and packaging standards for all products and all channels. This position will need to effectively interact with management, internal departments and external suppliers.

Essential Duties and Responsibilities Other duties may be assigned by supervisor or management. In the event of absence, duties for this position will be overseen by the position to which it reports.

  • Serve as the subject matter expert (SME) regarding regulatory compliance, labeling and nutritional statement matters.
  • Set the labeling standards and guidelines for all products.
  • Act as an advocate for customer regulatory issues regarding label compliance.
  • Identify, manage and implement process improvements as it relates to the management of regulatory information.
  • Respond to internal and external customer product, ingredient or nutritional questions.
  • Primary liaison for marketing and suppliers regarding product naming, claims and overall package label integrity.
  • Maintains up to date knowledge on FDA and USDA regulations and policies and helps the business prepare for changes in regulations.
  • Communicate the relevant updates to internal stakeholders regarding food labeling regulations.
  • Assure full regulatory compliance.
  • Active engagement in Innovation / Renovation contributing effectively to I/R process from ideas to preparation of launches; by providing regulatory perspective for new and renovated products including labeling, claims and ingredients; by identifying and resolving regulatory hurdles as early as possible.
  • Apply a ‘compliance by design’ approach to assure supplier process capabilities are confirmed to deliver on claims and product characteristics.
  • Validate product labeling, new product descriptions and marketing materials.
  • Lead frequent vendor communication from initial conception into fully labeled product packaging. Help facilitate label change control through communication with stakeholders to assure proper transition between labeling and packaging changes.
  • Collaborate with team members and suppliers to support the policies, programs and certifications such as Organic, Gluten-free, Non-GMO, etc. used across the company.
  • Engage with external regulatory authorities, trade associations and other health professional organizations with compliance issues impacting the Company or Industry at large.
  • Overall lead of specification system.
  • Administration of reviews of HS/ Schedule B code classifications specific to export to Canada.

Qualifications (Include Education and Specific Experience)

  • BS in Nutrition, Food Science, Food Law or related degree in scientific field
  • Minimum 5 years of experience in the food industry, specifically regulatory, labeling and claims
  • Minimum 3 year proven track record with experience managing and leading cross functional teams
  • Regulatory Affairs Certified (RAC), preferred
  • Knowledge of and experience with FDA and USDA food regulations, specifications and labeling databases
  • Full understanding of Genesis R&D database and the USDA nutrient database
  • Ability to work independently, multi-task and prioritize multiple projects and tight timelines in a fast-paced environment
  • Familiarity with Microsoft applications and Adobe PDF software

Competencies 

Accepting Direction – Accepts and follows directions from others; respects authority; complies with requests; does what they are asked to do

Coordinating Project Activities – Communicates project goals, timelines, and milestones; lets people know what they need to accomplish; identifies project interdependencies and potential resource constraints; follows up with others to ensure they are on track to meet project goals

Delivering High Quality Work – Critically reviews work processes to ensure quality; addresses problems that could impact quality; makes sure project deliverables and services meet all requirements and expectations; does not make the same mistakes twice

Demonstrating Initiative – Takes action on his/her own without being prompted; handles problems independently; able to resolve issues without relying on extensive help from others; does more than is expected or asked Driving for Results Aggressively pursues challenging goals and objectives; will to put in considerable time and effort to accomplish objectives; takes a highly focused, goal driven approach toward work

Driving Projects to Completion – Keeps current on project status; makes sure people are aware of project status and what they need to do to keep things moving; redirects project resources and activities to overcome setbacks; elevates project concerns to senior levels of leadership when appropriate

Interacting with People at Different Levels – Comfortable interacting with people at all levels of the organization; adjusts style of conversation based on the audience; uses words and messages appropriate given the background and interests of the people he/she is talking to

Managing Time – Accurately estimates time required to complete actions and activities; adheres to schedules and timetables; completes things when he/she said they would; sensitive to the use of other people’s time

Navigating Organizations – Understands how work gets done in organizations; builds networks that allow him/her to efficiently drive projects through the organizational structure; maximizes productivity while staying within constraints of formal organizational policies and rules

Prioritizing and Organizing Work – Allocates time and attention based on what is the most important to achieve key goals and objectives; approaches work in an organized and systematic manner; effectively manages tasks, information, and requests

Supporting Coworkers – Responds positively to requests; helps others achieve their goals; considers how his/her actions will impact others; looks for ways to contribute to the team

Using Computers and Technology – Adept at using computers and other forms of technology related to his/her job; keeps up to date on technological changes; adapts work approach to keep pace with innovations in technology

Working with Ambiguity – Achieves forward progress in the face of poorly defined situations and/or unclear goals; able to work effectively with limited or partial information

Culture

  • Focused – We prioritize our activities and act with a sense of urgency on those initiatives which will meaningfully move our business forward.
  • Accountable – We take responsibility for our commitments, decisions and actions and own the results regardless of the outcome.
  • Customer-Centric – We honor our customers with a commitment to genuine service.
  • Team-Oriented – We are “all hands in” – we work, win, and overcome trials as one company.
  • Solution-Driven – When faced with problems, we come equipped with solutions. Leadership Success Profile
  • Earning Trust & Confidence – Demonstrating values and personal competence
  • Shaping the Future – Developing a strategy for long-term growth
  • Developing Self & Others – Building and leveraging individuals’ capabilities
  • Leading Transformation Change – Inspiring commitment and momentum
  • Delivering Long-Term Value – Achieving superior performance through operating excellence

For more information, please contact Susan Canarick at OPUS International, Inc. 954 428-3888 or e-mail: susanc@foodscience.com