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Bloomingdale

    scientist ii regulatory specialist - BLOOMINGDALE, United States - NOW Foods

    NOW Foods
    NOW Foods BLOOMINGDALE, United States

    4 weeks ago

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    Description
    ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.


    Analyzes and interprets advanced scientific and biomedical research web-based, peer-reviewed and vendor-sourced technical materials pertaining to ingredients, technologies, clinical studies, physiology, chemistry and safety in order to create recommendations, develop product concepts, write and substantiate structure/function (S/F) claims and other marketing materials.

    Writes and substantiates structure/function claims for all NHG products (NOW, Protocol For Life Balance and NOW Sports) and reviews/approves all product label text for these brands as well as for Private Label, NOW Real Foods, NOW Solutions and NOW Pets.

    Reviews and provides in-depth regulatory compliance recommendations for all NHG marketing materials including ads, flyers, brochures, consumer reviews, and other published product literature to ensure compliance with FDA DSHEA regulations and FTC guidelines.

    Reviews and approves/rejects consumer reviews on the NOW website via Bazaarvoice platform.

    Develops new product concepts and evaluates all evidence-based healthcare practitioner targeted products (Protocol) in collaboration with New Product Development (NPD) teams.

    Provides training on the application of DSHEA regulation and FTC guidelines for dietary supplement product labeling and marketing advertising for both internal and external groups.

    Provides training on products and product categories, as well as on the science of supplements for both internal and external groups.

    Writes technical articles and develops marketing materials that reflect the science behind product formulations while maintaining compliance with federal regulations (as outlined by FDA/FTC) upon request.

    Provides technical and regulatory support to the Legal Dept. on matters requiring up-to-date scientific and/or current regulatory compliance as needed.

    Acts as a back-up on selected tasks for other scientists within the group.

    Stays abreast of industry and academic advances through participation in trade and scientific memberships, product technical bulletins, and participating in trade and scientific conferences.

    Manages multiple projects involving scientific analysis and/or technical writing.

    Complies with safety and GMP requirements.


    SAFETY RESPONSIBILITY STATEMENT
    Supports a culture of safe production and operations; follows all safety rules and procedures.

    Actively participates in the safety program by:

    engaging in training activities to learn what constitutes a safety hazard; reporting safety concerns to the supervisor, submitting safety suggestions, and correct or report to the appropriate people when you see a workplace health or safety hazard, until it is resolved.

    Assists with communicating safety information to new employees. Fulfills responsibilities as outlined in the company safety management plan.


    QUALIFICATIONS
    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

    EDUCATION and/or EXPERIENCE

    Ph.
    D.

    or Master's degree from an accredited university in Nutrition, Chemistry, Biology, Biochemistry, or biomedical/nutritionally related science is preferred or related scientific studies is required.

    A minimum of five years of experience in scientific research and development and/or five years of scientific and professional experience directly related to FDA and DSHEA regulations (Structure/Function claims, nutrient content and FDA approved health claims) is required.

    A working knowledge of nutritional biology, chemistry, biochemistry, microbiology or biomedical sciences is required.


    LANGUAGE SKILLS
    Ability to read, analyze, and interpret biomedical periodicals, professional journals, technical procedures, or legal/patent documents. Ability to write technical and regulatory affairs compliance reports, business correspondence, technical articles, and procedure manuals, patent applications.

    Ability to effectively present information and respond to questions from groups of managers, scientists, coworkers and external Supplier/business development representatives.


    OTHER SKILLS AND ABILITIES
    Excellent time management, attention to detail, verbal and written communication skills, listening, decision-making, and organization skills required. Excellent computer skills required, including proficiency with Microsoft Word, Excel and scientific databases. Oracle experience is preferred. Internet key word searches, on-line biological and medical databases are essential.


    REASONING ABILITY
    Excellent problem-solving skills.


    PHYSICAL DEMANDS

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


    WORK ENVIRONMENT

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Travel requirements including via air
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