Regulatory Specialist I jobs in United States
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Lyons Magnus · 20 hours ago

Regulatory Specialist I

Lyons Magnus is an international food and beverage manufacturer headquartered in Fresno, California. The Regulatory Specialist I will support the Regulatory Department by ensuring accurate completion of technical documentation, labeling claims, and formula management while partnering cross-functionally to balance business objectives with compliance requirements.

Food and BeverageManufacturing

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

Qualification

Regulatory technical knowledgeHealth Care regulatory claimsTechnical documentationProject managementInterpersonal skillsMulti-taskingCustomer service focusProblem-solving skillsWritten communicationOral communicationAttention to detail

Required

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
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

Preferred

International compliance experience is a plus

Benefits

Health, Dental Insurance
Life Insurance
Long Term Disability
Sec. 125
401(k) plan
And more

Company

Lyons Magnus

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Lyons Magnus develops and markets quality products with innovative packaging to meet the needs of Foodservice, and International customers.

Funding

Current Stage
Late Stage
Total Funding
unknown
2017-01-01Private Equity

Leadership Team

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Jim Davis
Chief Executive Officer
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Jon Parker
Sr VP, Chief Information Officer & PMO
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Company data provided by crunchbase