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General Description
The R&D Regulatory Associate is responsible for all aspects of product label review, product claim development and substantiation, and other regulatory-related activities in compliance with Good Manufacturing Practices, customer & business requirements & procedures. Assists Sales, Manufacturing, Procurement, Quality and other functional areas.
Essential Job Duties/Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential job functions. Essential job functions and duties include, but are not limited, to:
Reviews customer product labels to ensure alignment to formulation and/or specifications, and compliance with regulatory requirements. Provides and communicates risk assessment to internal and external customers.
Develops & maintains label verification processes and procedures; monitor, evaluate, recommend and implement improvement opportunities.
Reviews scientific literature, creates and substantiates nutrient and structure function claims, writes position papers and other scientific articles.
Negotiates labeling-related requests from internal customers, and business partners based on current and anticipated future regulations.
Creates DSHEA & NLEA-compliant labels, Finished Product Specifications and other technical documentation relevant to product development .to ensure on-going compliance with business needs & requirements.
Supports customers with regulatory-related inquiries, and questioners.
Assists in tracking and coordinating incoming product quotation requests.
Assist R&D Staff, Sales, Quality, Procurement and other functions.
Complies with all Company policies and procedures, including safety rules and regulations.
Maintains a safe work environment and operates in a safe manner.
Perform other job duties related to the job, as assigned by management.
Qualifications
QUALIFICATIONS
The requirements listed below are representative of the knowledge, skills, education, and/or abilities required for the job:
Excellent written and oral communications skills with high level of attention to detail.
Excellent planning & organizational skills and ability to self-manage for managing numerous priorities.
Detailed understanding of U.S. Labeling laws & FDA regulations (Food additives, Nutrition, Standards of identity, etc.)
Proficient PC skills (Microsoft Word, Excel, PowerPoint, typing (min. 45-50 wpm)).
Effective problem-solving skills.
Knowledge of general office skills and administrative procedures, including, but not limited to: filing, copying, faxing, editing, and development of memos, letters, reports, and correspondence.
Ability to work independently and in a team environment.
Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management, employees, and other individuals that interact with this position.
Ability to comply with Company policies, procedures, work rules, and protocols.
Ability to adapt effectively to workplace changes and new job duties/responsibilities.
Ability to represent the Company in a positive and professional manner at all times.
Ability to comply with Company policies, procedures, work rules, and protocols.
Ability to adapt effectively to workplace changes and new job duties/responsibilities.
Ability to represent the Company in a positive and professional manner at all times.
SELECTION GUIDELINES
Required
The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:
Associate Degree in Food Science, Chemistry, Pharmacy, or other relevant science is desirable (Four-year college or university degree is preferred); plus
3 or more years of work experience in Nutraceutical, Food, Pharmaceutical, or related industries; or
Any combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successfully perform the job.
PHYSICAL DEMANDS & WORKING CONDITIONS
The essential functions of this job require the employee to perform the following physical activities during the course of work:
Communicates orally with management, employees, co-workers, vendors, suppliers, governmental compliance agencies, and the general public by telephone or in person, in one-on-one or group settings.
Regularly uses a telephone, computer (e-mail) and fax for communication.
Required to stand, walk, and sit for extended periods of time during the course of work shift.
Routinely required to stoop, bend, kneel, lift, reach, pull, push, and tilt object in the performance of job function.
Requires the essential use of hands, speech, eyesight, and hearing.
Lifting limitations for this position: 25-30 lbs. May have to manipulate heavier containers.
Vision requirements include close and distance vision, color vision, peripheral and depth vision, and the ability to adjust focus as needed.
Requires incumbent to sit and operate computer for extended periods of time during course of work day, and the ability to proficiently use the computer key-board for typing.
Noise level for this work environment is typically low to moderate. Some work areas require hearing protection for an 8-hour work day.
Periods of odoriferous environment.
Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, unpleasant odors, and/or loud noises. Personal Protective Equipment provided as necessary.
Work environment may involve exposure to chemicals, solutions, detergents, or solvents that require following extensive safety precautions and may include the use of personal protective equipment.
Work environment may involve exposure to allergens such as Soy, Wheat, Fish, Shell Fish, Milk, Egg, Tree nuts, and Sesame.
Note : The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employee’s employment term, at the sole discretion of management.
Best Formulationsis an equal-opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet accommodation needs that are made known to Best Formulations in advance.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Manufacturing
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