NOW Foods
REGULATORY AFFAIRS DOCUMENTATION MANAGER
NOW Foods, Bloomingdale, Illinois, United States, 60108
Regulatory Affairs Documentation Manager
Job Category : SCIENCERequisition Number : INTER004247Posted: October 2, 2024Full-TimeOn-siteLocations
Showing 1 location:KNOLLWOOD - CORPORATE OFFICEBLOOMINGDALE, IL 60108, USADescription
ESSENTIAL DUTIES AND RESPONSIBILITIES
include the following. Other duties may be assigned.Prepares and submits international new product registrations, renewal of registrations, certificates, and other required documents to regulatory authorities.Responsible for interacting with government regulatory agencies (such as FDA, USDA, and international agencies as necessary) regarding registration processes for procedures requiring regulatory approval.Functions as the primary liaison between Sales, QA/QC/R&D, and the Purchasing Groups to obtain the necessary documentation supporting international and domestic trade requirements for all countries (excluding Canada) where NOW products are registered or sold.Organizes periodic meetings with Sales to determine project priorities and update progress on requested actions.Provides technical supervision to the Documentation Team and serves as a regulatory resource for documentation requirements in the various countries where products are registered and where Sales request registration and documents.Establishes SOPs for registration and sales support and reviews and verifies all QA information for Certificates of Free Sale, government-generated certificates, CofA, specifications, master formulas, FDA inspection reports, and GMP compliance.Complies with safety and cGMP.Supervisory Responsibilities:Directly manages the International Regulatory Affairs Specialists. Carries out managerial responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; and consistently following and enforcing Company policies.Safety Responsibility Statement:Supports a culture of safe production and operations; follows all safety procedures. Responsible for safety performance in respective areas. Responsible for incident investigations, job hazard analyses, risk assessments, inspections, training, employee involvement, and enforcement of workplace health and safety policies and requirements. Acts as the primary communicator of safety information in the department. Encourages employees’ participation in the safety effort. Fulfills responsibilities as outlined in the company safety management plan.Qualifications:To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. 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 essential functions.EDUCATION and/or EXPERIENCE:A bachelor’s degree (BS, BA) in physical or biological science, nursing, and/or psychology is required, as is three to five years of experience in a QA or QC role (pharmaceutical or medical device industry). Export documentation and/or registration experience is preferred. Working knowledge of FDA regulations, label compliance, and import/export regulations pertaining to Dietary Supplements and Food is preferred.Language Skills:Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports and business correspondence. Ability to effectively present information and respond to questions from managers, clients, customers, and the general public.Reasoning Ability:Excellent problem-solving skills are required.Other Skills/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 and Excel. Oracle experience is preferred. Must possess strong organizational, leadership, and project management skills, be a self-starter, and be able to handle multiple tasks. Must possess a professional attitude and work well with peers and management.Physical Demands:The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.While performing the duties of this job, the employee is regularly required to sit, talk, and hear. The employee occasionally is required to stand, walk, and reach with hands and arms. The employee is required to use a telephone and a computer regularly. Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus.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 essential functions.The employee is expected to travel to conferences and customers, including air travel occasionally.
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Job Category : SCIENCERequisition Number : INTER004247Posted: October 2, 2024Full-TimeOn-siteLocations
Showing 1 location:KNOLLWOOD - CORPORATE OFFICEBLOOMINGDALE, IL 60108, USADescription
ESSENTIAL DUTIES AND RESPONSIBILITIES
include the following. Other duties may be assigned.Prepares and submits international new product registrations, renewal of registrations, certificates, and other required documents to regulatory authorities.Responsible for interacting with government regulatory agencies (such as FDA, USDA, and international agencies as necessary) regarding registration processes for procedures requiring regulatory approval.Functions as the primary liaison between Sales, QA/QC/R&D, and the Purchasing Groups to obtain the necessary documentation supporting international and domestic trade requirements for all countries (excluding Canada) where NOW products are registered or sold.Organizes periodic meetings with Sales to determine project priorities and update progress on requested actions.Provides technical supervision to the Documentation Team and serves as a regulatory resource for documentation requirements in the various countries where products are registered and where Sales request registration and documents.Establishes SOPs for registration and sales support and reviews and verifies all QA information for Certificates of Free Sale, government-generated certificates, CofA, specifications, master formulas, FDA inspection reports, and GMP compliance.Complies with safety and cGMP.Supervisory Responsibilities:Directly manages the International Regulatory Affairs Specialists. Carries out managerial responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; and consistently following and enforcing Company policies.Safety Responsibility Statement:Supports a culture of safe production and operations; follows all safety procedures. Responsible for safety performance in respective areas. Responsible for incident investigations, job hazard analyses, risk assessments, inspections, training, employee involvement, and enforcement of workplace health and safety policies and requirements. Acts as the primary communicator of safety information in the department. Encourages employees’ participation in the safety effort. Fulfills responsibilities as outlined in the company safety management plan.Qualifications:To perform this job successfully, an individual must be able to satisfactorily perform each essential duty. 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 essential functions.EDUCATION and/or EXPERIENCE:A bachelor’s degree (BS, BA) in physical or biological science, nursing, and/or psychology is required, as is three to five years of experience in a QA or QC role (pharmaceutical or medical device industry). Export documentation and/or registration experience is preferred. Working knowledge of FDA regulations, label compliance, and import/export regulations pertaining to Dietary Supplements and Food is preferred.Language Skills:Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports and business correspondence. Ability to effectively present information and respond to questions from managers, clients, customers, and the general public.Reasoning Ability:Excellent problem-solving skills are required.Other Skills/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 and Excel. Oracle experience is preferred. Must possess strong organizational, leadership, and project management skills, be a self-starter, and be able to handle multiple tasks. Must possess a professional attitude and work well with peers and management.Physical Demands:The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.While performing the duties of this job, the employee is regularly required to sit, talk, and hear. The employee occasionally is required to stand, walk, and reach with hands and arms. The employee is required to use a telephone and a computer regularly. Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus.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 essential functions.The employee is expected to travel to conferences and customers, including air travel occasionally.
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