DOCUMENTATION & REGULATORY AFFAIRS SPECIALIST II at NOW Foods

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following and other duties as assigned.

•Provides the required technical documentation to support regulatory and registration requests for the NOW Sales Teams. This responsibility includes but is not limited to COAs, product specifications, vendor quality documents, allergen statements, non-GMO statements, product labels, Organic, Kosher and Halal certificates, Certificates of Free Sale, Phytosanitary certificates and other product/ingredient government-based certificates for sales.

•Procures technical information from QA/QC databases for the NOW sales teams for regulatory and registration requests.

•For documentation and registration work, confirms accuracy and correctness of documentation from master formula to label listing of ingredients, content and claims, conformance to GMP and other regulatory requirements. Alerts team manager, quality and sales teams of any discrepancies found.

•Interacts and collaborates directly with a government agency, such as the FDA, USDA, NOAA or IL Dept of Public Health to apply for and obtain certificates for various product categories or ingredients such as fish oils, dairy, gelatin, plant and animal-based ingredients to support sales.

•Develops a tracking system and monitors accordingly to ensure delivery of all required documentation at the expected deadline.

•Maintains regulatory and registration files of all work and documents provided to the sales teams.

•Complies with safety and GMP requirements.

SAFETY RESPONSIBILITY STATEMENT
Supports a culture of safe operations; follows all safety rules and procedures. Actively participates in any safety programs by engaging in training activities to learn what constitutes a safe work environment. 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
Associate’s degree from a two year post high school college or bachelor's degree (BA or BS) from four-year college or university with a related degree in biology, chemistry, nutrition and/or quality/regulatory compliance with 4 years of experience collaborating with a government regulatory agency preferred.
LANGUAGE SKILLS
Ability to read, analyze, and interpret science-based documents, general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports and business correspondence. Ability to effectively present information/documentation and respond to questions from manager, colleagues, and customers.
OTHER SKILLS AND ABILITIES
Excellent interpersonal, organizational skills and attention to detail required. Good computer skills required, including proficiency with Word and Excel. Oracle and LIMS experience and other quality technical databases a plus.
REASONING ABILITY
Problem solving skills required.
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
Desk and office 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.