As a Senior Regulatory and Labeling Specialist at our clients company, you will play a crucial role in ensuring that finished product labels meet the strict requirements of FDA Labeling Laws and 21 CFR Regulations. Your responsibilities will include the review, verification, and approval of labels within the company portfolio, ensuring compliance, accuracy, and integrity.
Key Duties and Responsibilities:
- Create and amend labels as new product revisions occur, ensuring they are updated in line with FDA Code updates.
- Support labels for multiple facilities and various brands within the company portfolio.
- Utilize systems to validate that the information on Nutrition Facts Panels (NFP) and Ingredient Lists (ILS) can be used for verification against artwork.
- Identify errors within ingredient subcomponents and collaborate with FSQA Supplier Qualification to correct them.
- Research subcomponents of ingredients to ensure the accuracy of ILS and NFP.
- Demonstrate a full understanding of claims, certifications such as Kosher, Halal, non-GMO/BE Foods, Organic, NSA, Disclosure Statements, and more.
- Develop knowledge of label regulations in foreign countries and utilize external consultants to meet foreign business requirements.
- Collaborate in the FSQA label review and approval process, working with cross-functional teams and managing multiple simultaneous tasks with multiple inputs.
- Handle projects requiring a short turnaround time, prioritize work, and effectively communicate to set expectations.
- Stay up-to-date with changes in regulatory legislation and guidelines and offer advice about regulations.
Work Experience/Requirements for This Role:
- A Bachelor of Science (BS) in Food Science or a closely related field preferred
- 5+ years of working experience in Regulatory Label Development and/or Regulatory Compliance preferred
- Strong working/expert knowledge of FDA 21 CFR Labeling Requirements.
- Experience with Genesis R&D Food Labeling software.
- Strong verbal and written communication skills.
- Previous experience utilizing basic computer applications (MS Word, Excel, PowerPoint, and internet navigation).
- Demonstrated high-level quantitative and analytical skills.
Schedule:
Work Location:
Benefits:
- 401(k) matching
- Dental insurance
- Disability insurance
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Tuition reimbursement
- Vision insurance
Ascendo is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.the basis of disability
