Regulatory Compliance Specialist

• Interpret 21 & 7 Code of Federal Regulations (CFR) requirements for foods, dietary supplements, and drugs as they apply to compliant labeling.
• Use regulatory-related information systems (i.e., SAP, Product Lifecycle Management [PLM], Lytho) to execute compliant label change processes.
• Manage PLM label phrases, incorporating raw material and trademark changes, ensuring all the necessary data has been provided and is accurate the PLM system.
• Systematically build Label Data Sets – i.e., the Supplement Facts (SF), Nutrition Facts (NF), and Drug Facts -- for label purposes, using the Product Life Management (PLM) system. This includes obtaining data on formulations, raw materials (RM) / allergens, warnings, recommendations, etc., and ensuring correct formula set-up in PLM. 
• Perform regulatory review and approval of product primary packaging for compliance with federal regulations and corporate policies, as well as ensuring formulation and labeling accuracy.
• Trouble-shoot issues within PLM system and help facilitate continuous expansion of PLM attributes for executing process improvements.
• Perform finished good specification review and oversee PLM packaging specification content to ensure accuracy of PLM Label Information Report and ensure all changes to labeling are correct in PLM.
• Responsible for executing National Drug Code changes and annual filings to FDA for compliant change control of OTC drugs primary packaging.
• Represent Regulatory Compliance to internal stakeholders and other site projects as assigned.
• Back-up for Pharma Compliant Analyst: serious adverse event reporting to FDA
• Support and train in Regulatory Compliance/Product Integrity & Compliance policies as needed.
• Support of Salsify data integrity for accurate syndication of label and marketing content.

• Must have multi-task project organizational skills.
• Ability to balance multiple priorities, support projects with a great degree of flexibility, and meet deadlines in a fast-paced environment.
• Ability to work independently and as a team player who works well as a member of a diverse team.
• Strong investigative, organizational, analytical, and problem-solving skills.
• Ability to focus on details for long periods of time and be very detail oriented.
• Strong interpersonal skills with the ability to influence others in a positive and effective manner.
• Ability to learn computer-based programs, such as Lytho and PLM.

• BA/BS degree in health, nutrition, food science, science discipline or related field required. Further coursework in quality, risk management, chemistry, biology or related field is helpful.

• Experience in food, drug, or dietary supplement environments required with knowledge of regulations outlined in 21 CFR Parts 101,111,117, 201, 210, and 211; 7 CFR Parts 66 and 205.

• Excellent organizational skills and ability to support/manage multiple projects.

• Guidances, Commission E monographs, Canadian monographs, harmonized international regulations (ICH, WHO, and others) and legal regulatory documentation. Ability to understand expert reports related to a product.

• Effectively present information and respond to questions from management, cross-functionally, and with customers.
• Ability to communicate effectively both verbally and written.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.

As a Nature’s Way employee, you’ll enjoy a wide variety of benefits that offer the support you need to truly live what you believe.

All benefits are effective on day ONE of your employment!

Medical      Option to select either a PPO plan or one of 2 high – deductible medical plans that includes a company contribution to your personal health savings bank account.

Dental Delta Dental PPO & an option to select an enhanced dental plan.

Vision Routine preventative coverage under medical plan and an option to elect additional voluntary coverage

Time Off All employees receive 11 holidays off per year, as well as paid time off that starts at a minimum of two weeks per year.

401K Plan Company match of up to 4% as long as employees contribute a minimum of 6% to the account. An additional profit-sharing contribution is also made to employee accounts if the company meets its annual targets.

You’ll also enjoy a variety of other benefits that support your long-term health and wellness:

• Company provided short-term & long-term disability
• Life and AD&D insurance
• Flexible spending accounts
• Voluntary critical illness & accident coverage
• New parent phase-in program & paternity leave
• Educational assistance reimbursement
• Product discounts & a wellness program
• Free Fitness Center

Start Helping People live Healthy lives today!

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)