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Regulatory Affairs Specialist

The Regulatory Affairs Specialist, Ingredients works independently to research, interpret, and apply food labeling/ingredient principles to Regulatory recommendations and provide information to Regulatory managers as needed for decision-making.
This person represents Regulatory in ingredient-based team meetings, including collaboration with Legal, and conducts regulatory research on ingredients, including coordination with ingredient suppliers. Will be the Regulatory SME for product claims requirements focusing on formula and ingredient claims. This role works collaboratively with Regulatory colleagues to assess risks tied to product labeling, ingredient specifications, claims, interpretation of regulations, etc. This position contributes/identifies/promotes innovations related to ingredient use and makes technical recommendations and present back to the business. Complete Regulatory reviews and assessments to ensure compliance with Federal and State regulations.
Key Responsibilities include:
  • Regulatory Ingredient Support (Representation, Documentation and Process Control, and Regulatory Vigilance): Represent Regulatory on internal ingredient teams/projects such as the Hill’s Ingredient Team, Procurement/Implementation & Support Team, and special projects as needed. Serve as a representative on ingredient based Trade Association subcommittees to advance industry interests, supervise trends, raise critical issues and keep the business advised. Work independently with colleagues such as Science & Technology (S&T), Marketing, Procurement, and Quality to provide support in areas such as: applications/regulatory status of different ingredients (current and under research) and Regulatory implications/claims tied to those ingredients, etc. Develop Regulatory recommendations and build relevant Standard Operating Procedures, Work Instructions, POV’s and policy guidelines (as needed). Support ingredient registrations, submissions, and packaging reviews. Support U.S. and global ingredient innovation and implementation strategies by ensuring compliance through assessments and research, making recommendations to the business. Support Quality in qualifying ingredient suppliers and performing document audits. Coordinate with Global Regulatory and partners to prepare requests for definitions for unapproved ingredients with Regulatory authorities.
  • Process and Systems Review/Management: Maintain Regulatory Assessment process, as needed, to provide and detail mentor ship regarding regulatory issues impacting broader business decisions or cross- functional processes. Supervise and provide ongoing ingredient maintenance in Hill's labeling software and matrices in order to help ensure consistency and compliance.
  • Regulatory Intelligence: Monitor changes in regulatory environment and trends as they affect ingredients (of interest to Hill’s and its suppliers), labeling, claims, etc. in U.S. and globally. Develop subject matter expertise of Hill’s ingredient systems and strategy/implementation goals. Understand and communicate business and of global ingredient changes. Maintain intelligence files, keeping them current and available to relevant staff. Challenge existing models, build and foster new ones as opportunities arise.
  • Other Duties as Assigned: Develop in-depth knowledge of Hill’s Regulatory to include an understanding of functional key business partnerships. Represent the department on cross-functional teams, support preparation of official communication tied to ingredients/claims, as needed. Support Legal requests for information/research, such as historical information tied to ingredient assessments/claims/mentor ship and current interpretation of regulations tied to ingredients and related claims. Establish credibility and foster mutually encouraging global relationships through good communication practices.
What I need?
  • Bachelor’s degree in business, policy, natural sciences or related field
  • Minimum of 4 years of work experience, with 2 years preparing registration submissions and/or handling regulatory ingredient issues.
  • Ability to coordinate information from various internal and external subject areas
  • Ability to research, interpret, and apply Federal, State, and International regulations
  • Ability to understand and align with domestic and international regulatory requirements
  • Ability to communicate verbally and in writing across all levels of the organization
  • Ability to follow specific directions and to request instructions for sophisticated tasks.
  • Intermediate proficiency Google tools, Microsoft Suite and SAP
  • Detail oriented & Good organization and planning skills
  • Able to balance multiple tasks in a timely manner; ability to be flexible with shifting priorities
  • High energy, proactive self-starter and self-directed
It's an advantage to have:
  • Master’s or PhD in business, policy, animal sciences or DVM
  • Minimum 3 years regulatory affairs, quality, compliance or legal work experience
  • Pet Food confirmed experience or a technical background in: Regulatory Science, Quality Assurance, Product-Development, Laboratory Sciences, or similar work experience.
Equal Opportunity Employer
Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.