Regulatory Affairs Specialist

Benefits:

• 401(k) matching
• Competitive salary
• Dental insurance
• Employee discounts
• Health insurance
• Paid time off
• Parental leave
• Vision insurance
  
  
  

Job Summary:The Regulatory Affairs Specialist is responsible for all aspects of the labeling process including the creation, development, review and implementation of the Nutrition/Supplement Facts panel and customers’ label for contract formulations. The role assists the Regulatory Manager and other associates within the Regulatory Department and works internally with Product Development, Sales/Customer Service and other internal functional areas to ensure the timely submission of the Regulatory documentation and compliance, and to support business objectives as required.

The Regulatory Affairs Specialist will review and approve Dietary Supplement/Food labels for technical accuracy and compliance to all mandated regulatory requirements, provide information to rectify label issues and assist in resolving issues related to the use of customers’ label for packaging.

Principal Responsibilities:

• Assist in the creation and update of the final Supplement/Nutrition Facts Panel (SFP/NFP) for new and existing products and ensure consistency of label with the master manufacturing formula and compliance with all applicable food/dietary supplement labeling regulations.
• Ascertain all the appropriate information that must appear in a SFP/NFP based on a finalized formulation utilizing the correct product information file respective to each ingredient in the formula.
• Accurately establish (where appropriate) what nutritional values must appear on the SFP/NFP and implement all relevant information that must appear on a finished product label utilizing the correct SFP/NFP format according to regulatory guidelines.
• Implement the necessary changes to any existing finished product labels due to product reformulation or ingredient/supplier change.
• Review, approve and provide finished product regulatory documents based on customers’ requirements or requests.
• Maintain and organize files for online and hard copy product label Master Copy book.
• Assist in gathering and reviewing raw materials documents and ensure the minimal required documents are provided by raw material vendors on time before the VHA Nutrition/ Supplement Facts panel is finalized/approved and that all other documents are requested, received and filed properly.
• Review and approve or reject customer labels, make suggestions, if needed, to rectify any errors to ensure compliance with all pertinent labeling regulations.
• Maintain excel sheets, used to create Nutrition/Supplement Facts, and ensure nutritional data and other information entered in the system are correct, complete and in compliance with pertinent labeling regulations.
• Assist in and ensure the timely and accurate completion of documents (Product Data Sheet, Allergen Statement, BE/GMO statement, etc.) and other regulatory requests and inquiries from external customers and from other departments in the company related to labeling compliance, product and ingredients information and documentation.
• Stay current on the evolving regulatory environment and share relevant information to other associates within the Regulatory department as well as all other departments in the company.
• Assist in other projects as needed and perform other related duties as assigned.
  
  
  

Additional Requirements:

To perform this job successfully, an individual must be able to perform each principal responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education: BS degree in Nutrition, Life Sciences, or nutrition-related discipline with at least two years of directly related experience in Regulatory Affairs within the food/dietary supplement manufacturing industry.

Experience: Knowledge of Dietary Supplement GMP guidelines and specific GMP documentation guidelines. Familiarity with food/dietary supplement ingredients and formulas. Knowledge of food/dietary supplement nutrition labeling regulations, including FDA nutrition labeling regulations. Conversant with regulatory guidelines for food/dietary supplements and familiarity with food/dietary supplement ingredients, formulas and manufacturing processes. Understand and interpret FDA regulations for nutritional labeling, rounding rules, percent daily values and other applicable technical/regulatory information for food/dietary supplements.

Physical Requirements: Work requires ability to regularly lift up to 10 pounds and occasionally lift up to 25 pounds; standing, walking, bending and/or stooping for periods of five hours or more; moving and examining objects at high and low reach, and reading for periods of three hours or more. Position requires normal visual acuity.

Additional Skills and Qualifications:

Knowledge of cGMP standards to ensure the maintenance of the cGMP standard of quality.

Adherence to health and safety regulations (e.g., constant use of protective gear).

Ability to read and interpret documents such as safety rules, operating and maintenance work instructions, procedure manuals and SDS sheets.

Must be able to effectively communicate orally and in written form in a cross functional team environment to complete work tasks as instructed.

Must be able to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and decimals and have the ability to solve moderately complex problems involving multiple variables in standardized situations.

Must understand and use simple statistical methods.

Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.

Must have ability to solve moderately complex problems involving multiple variables in standardized situations.

Must have a deliberate and acute sense of documentation of all activities while in the manufacturing environment.

Must be familiar with and be able to communicate via e-mail.

Must be experienced with the use of computer software and proficient in Microsoft Office Suite (Microsoft Word, Excel, Outlook), and ERP Systems.

Must have sound judgment and decision-making skills.

Demonstrated attention to detail, thoroughness and high level of organization are critical.

Ability to multi-task and work under pressure.