Regulatory Affairs Specialist

3-5 years

Not Disclosed

Mahwah

Openings: 12 Posted: June 17, 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

Summary

To ensure that all Flavor, Fragrance & feed formulations comply with industry, Federal/State, Global/International Regulatory bodies and customer requirements. To function as a liaison with internal departments (i.e. QA, Customer/Project Service, R&D, etc.) regarding the exchange and coordination of information required by our customers. Interface with multiple cross-functional internal groups/departments to execute timely and accurate completion of projects/assignments.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

Assist with Regulatory Database and Systems maintenance including but not limited to:

- Coordinate, prepare and review regulatory documents/certifications required for domestic and/or international projects (i.e. Specification Sheets, Safety Data Sheets (SDS), Flavor/Fragrance Allergens, GMO, Organic, Natural, IFRA, Country of Origin, GRAS, Kosher, Nutritional, etc.)

- Review Raw Material Documentation and enter related data into databases.
- Support the development of Regulatory Specifications.
- Alcohol and Tobacco Tax and Trade Bureau (TTB) filing of flavors.
- Prepare monthly Kosher Renewal certifications.
- Experience or exposure to pet and animal feed regulations.
- Utilize relevant information, internal tools and individual judgment to determine whether flavor and fragrance formulae comply with laws, regulations, and/or standards
- Other duties as assigned.
- Identify workload efficiencies to optimize procedures.

SUPERVISORY RESPONSIBILITIES:

Education and/or Experience

College Degree in Food Science, Nutrition Science or Science related subject, 1 to 5 years related experience and/or training or equivalent combination of education and experience may be acceptable.

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 calculate basic mathematical concepts such as addition/subtraction and others such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

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

Computer Skills

To perform this job successfully, an individual should have basic to Intermediate knowledge of Microsoft Office, Outlook, Word, Excel, and Power Point software. Experience in Regulatory Databases is preferred e.g. Trace Gains, Wercs, and other software systems.

Certificates, Licenses, Registrations

None required.

Other Skills and Abilities

Ability to multi-task and work independently with minimum supervision. Good interpersonal skills. Good attention to detail. Regulatory Knowledge as it relates to the Flavor & fragrance Industry. Team player. An interest and enthusiasm for Food, Flavor & Feed Regulatory knowledge.

Other Qualifications

None

Physical Demands

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, While performing the duties of this job, the associate is regularly required to talk or hear and taste or smell, The associate is frequently required to sit, The associate is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The associate may lift and/or move up to 25 pounds occasionally lab equipment.

Work Environment

The work environment characteristics described here are representative of those an associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the associate is 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.

Lucta is committed to the principles of equal employment and to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment that is inclusive and equitable, free of harassment, discrimination, or retaliation based upon an individual's age, race (including traits historically associated with race, which includes hair texture, hair type, and protective hairstyles such as braids, locks, and twists), color, national origin, ancestry, religion, sex, sexual orientation (including transgender status, gender identity, or expression), pregnancy (including childbirth, lactation, and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), military status (including status as a uniformed servicemember, a veteran, or dependent of a servicemember), or any other status protected by federal, state, or local laws. Lucta is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay and other compensation, termination, and all other terms, conditions, and privileges of employment.

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