Regulatory Specialist I

Lyons Magnus LLC•Walton, KY

5d•Onsite

About The Position

Lyons Magnus leads the food industry with creativity and innovation, crafting top-quality products across all manufacturing phases, from raw materials to marketing. With over 2000 diverse items for industrial ingredient and food service sectors, Lyons caters to leading restaurant chains nationally and internationally. At Lyons, our diverse and talented staff is the heart of our organization. We foster a thriving work environment where employees are engaged in shaping both the company's and their own future. A member in the Regulatory Department at Lyons Magnus, an international food and beverage manufacturer headquartered in Fresno, California. The position supports the Lyons Magnus Regulatory Department ensuring accurate completion of technical documentation, marketing claims, labeling claims, finished product label development, formula management, and export documentation. The Regulatory Specialist I will partner cross-functionally to balance business objectives with compliance requirements. Hours: 8:00 am - 5:00 pm Schedule: Monday - Friday (Must have some flexibility.) Location: Walton, KY Travel Requirements: None Work Environment: In - Office

Requirements

Strong interpersonal skills and demonstrated ability to work with cross functional teams, internally and externally
Individual must have regulatory technical knowledge
Ability to manage projects with short and long timelines
Demonstrated problem-solving skills (pays attention to details and effort to understand causes instead of just the effects) and creativity for developing innovative solutions and applications.
Excellent written and oral communication skills
Ability to effectively manage multiple projects under short time lines to produce commercially viable solutions.
Proven ability to multi-task in a fast paced environment
Prepare a variety of comprehensive administrative and technical documents and reports.
Read and process written information with high degree of accuracy.
Work effectively in a general business environment, with a focus on high level of quality, ethics and customer service.
Achieving results through others where no / little formal lines of authority exist
Minimum of B.S. Degree in Food or Nutritional Sciences, Biology, Chemistry or related field. Professional experience will be considered in lieu of a degree
2-7 years of relevant work experience within the food-manufacturing environment,
Experience in Health Care regulatory claims, labeling, customer interface, and technical documentation.
Must be computer literate and detail oriented.

Nice To Haves

International compliance experience is a plus.

Responsibilities

Lead the management of technical requests for all health care products manufactured by Lyons.
Develop regulatory documentation related to ingredients, formulations, and labels and ensure compliance with corporate and FDA regulations.
Complete technical document requests (statements to include specifications, nutritional composition, GMO, gluten, export certs, etc) to meet customer expectations in documentation turnaround time and accuracy.
Manage the regulatory process for commercialization of health care products for assigned customers (Label setup, internal specification documentation set up, customer product database set up etc).
Review and approve healthcare/nutrition product claims to ensure compliance with FDA, FTC, and other applicable regulations.
Substantiate claims with scientific evidence and maintain supporting documentation and advise Marketing, Sales, and R&D on compliant claim language and guardrails
Strategically manage large documentation projects and ability to support customer specific software programs.
Review and create unit labels and case coding in compliance with all FDA regulations and customer specific requests.
Review and Approve labels in compliance with all FDA regulations and provide guidance on product label and formula compliance in regions Lyons has a business interest.
Manage the formula entry and formula change process
Act as a lead for all regulatory export documentation (Certificates of Free Sale, Health and Quality Certs, Declarations) in Lyons Health Care.
Monitor regulatory changes and assess potential risks to claims or communications.
Responsible for reviewing respective required raw material documents for regulatory clarity.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards.
Serve as a Lyons Magnus representative / technical liaison with corporate and professional organizations where Lyons Magnus does business.
Ability to act as a back up to the Regulatory Manager as needed.
Performs other related and assigned duties by senior management.