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    Regulatory Affairs Specialist

    Lucta
    1-5 years
    Not Disclosed
    Mahwah
    10 July 1, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Regulatory Compliance Specialist

    Company: Lucta

    Summary

    The Regulatory Compliance Specialist ensures all Flavor, Fragrance, and feed formulations comply with industry, Federal/State, Global/International Regulatory bodies, and customer requirements. This role acts as a liaison with internal departments, such as QA, Customer/Project Service, and R&D, for the coordination and exchange of information required by customers. The specialist interfaces with multiple cross-functional internal groups to execute timely and accurate completion of projects and assignments.

    Essential Duties and Responsibilities

    • Regulatory Database and Systems Maintenance: Assist with the maintenance of regulatory databases and systems.
    • Documentation Preparation and Review: Coordinate, prepare, and review regulatory documents/certifications for domestic and international projects, including Specification Sheets, Safety Data Sheets (SDS), Flavor/Fragrance Allergens, GMO, Organic, Natural, IFRA, Country of Origin, GRAS, Kosher, Nutritional, etc.
    • Raw Material Documentation: Review and enter data related to raw materials into databases.
    • Regulatory Specifications Development: Support the development of regulatory specifications.
    • TTB Filings: Handle Alcohol and Tobacco Tax and Trade Bureau (TTB) filings for flavors.
    • Kosher Certification: Prepare monthly Kosher renewal certifications.
    • Pet and Animal Feed Regulations: Experience or exposure to pet and animal feed regulations.
    • Regulatory Compliance: Utilize relevant information, internal tools, and judgment to determine compliance of flavor and fragrance formulae with laws, regulations, and standards.
    • Efficiency Optimization: Identify workload efficiencies to optimize procedures.
    • Other Duties: Perform additional tasks as assigned.

    Supervisory Responsibilities

    • None

    Education and Experience

    • Degree: College degree in Food Science, Nutrition Science, or a related subject.
    • Experience: 1 to 5 years of related experience and/or training, or an equivalent combination of education and experience.

    Language Skills

    • Ability to read, analyze, and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
    • Ability to write routine reports and correspondence.
    • Ability to speak effectively to stakeholders.

    Mathematical Skills

    • Ability to work with basic mathematical concepts, including addition, subtraction, fractions, percentages, ratios, and proportions.

    Reasoning Ability

    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Ability to interpret a variety of technical instructions in mathematical or diagram form.

    Computer Skills

    • Basic to intermediate knowledge of Microsoft Office (Outlook, Word, Excel, PowerPoint).
    • Experience with regulatory databases (e.g., TraceGains, Wercs) is preferred.

    Certificates, Licenses, Registrations

    • None required.

    Other Skills and Abilities

    • Ability to multi-task and work independently with minimal supervision.
    • Good interpersonal skills and attention to detail.
    • Regulatory knowledge related to the Flavor & Fragrance industry.
    • Team player with an interest in Food, Flavor & Feed Regulatory knowledge.

    Physical Demands

    • Regularly required to talk or hear, and taste or smell.
    • Frequently required to sit.
    • Occasionally required to stand, walk, use hands to finger, handle, or feel; reach with hands and arms; climb or balance, stoop, kneel, crouch, or crawl.
    • May occasionally lift and/or move up to 25 pounds of lab equipment.

    Work Environment

    • Occasionally exposed to wet and/or humid conditions, moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and outside weather conditions.
    • The noise level in the work environment is usually moderate.
    • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Equal Employment Opportunity

    Lucta is committed to the principles of equal employment and compliance with all federal, state, and local laws providing equal employment opportunities. Lucta maintains an inclusive and equitable work environment, free from harassment, discrimination, or retaliation based on age, race, color, national origin, ancestry, religion, sex, sexual orientation, gender identity, pregnancy, physical or mental disability, genetic information, military status, or any other status protected by law. Lucta ensures non-discrimination in all aspects of employment, including recruiting, hiring, placement, transfer, training, promotion, compensation, termination, and all other terms, conditions, and privileges of employment.

     

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