International Vitamin
Coordinator, Regulatory Affairs
International Vitamin, Anderson, South Carolina, us, 29622
Overview:
The Regulatory Affairs Coordinator is responsible for providing regulatory, technical and administrative support to the International Regulatory Affairs Department. The role will include performing activities required to support product and facility registration for IVC and its customers.Responsibilities:Prepares standard registration and shipping documents requested by IVCs customersDelivers all documentation requests from both internal and external customers within agreed timelines and tracks progress and updates the client accordinglyCoordinates testing requirements for special projects such as No-no claims having labeling impact in accordance with the facilities standard operating proceduresRetrieves and compiles lab data using Labworks and Excel spreadsheets to support No-no claims for each productMaintain departmental files, forms, trackers, certifications, registrations and related documents in SharepointProvides additional assistance and administrative support to Regulatory Affairs and Customer Service agents as neededProvide administrative support for International Regulatory Affairs Team members as neededQualifications:
2 years+ experience as administrative assistant within a nutraceutical/food/science related or similar organizationTwo-year degree in technical degree in a related field (i.e. chemistry, technology, or business)IT savvy with new programs and experience with Microsoft Office, especially MS ExcelDetail oriented with high organizational skills, and prioritization of tasks or projectsExcellent verbal and written communication skills, problem solving, team building and interpersonal skillsHighly analytical and able to evaluate, analyze, and summarize large volumes of data and technical material efficiently such as lab reports, specifications and operational recordsKnowledgeable of administrative and clerical procedures and systems such as managing files and records, designing forms and other office dutiesMust be knowledgeable in cGMP requirements and familiar with the concept of Quality programsMust be a self-directed individual who works under minimal supervisionMust be knowledgeable and compliant with all IVC company policies and SOP/WIsMust maintain document compliance with FDA and foreign Regulations/GuidelinesMust be acquainted with and adhere to country specific regulations governing document preparation
The Regulatory Affairs Coordinator is responsible for providing regulatory, technical and administrative support to the International Regulatory Affairs Department. The role will include performing activities required to support product and facility registration for IVC and its customers.Responsibilities:Prepares standard registration and shipping documents requested by IVCs customersDelivers all documentation requests from both internal and external customers within agreed timelines and tracks progress and updates the client accordinglyCoordinates testing requirements for special projects such as No-no claims having labeling impact in accordance with the facilities standard operating proceduresRetrieves and compiles lab data using Labworks and Excel spreadsheets to support No-no claims for each productMaintain departmental files, forms, trackers, certifications, registrations and related documents in SharepointProvides additional assistance and administrative support to Regulatory Affairs and Customer Service agents as neededProvide administrative support for International Regulatory Affairs Team members as neededQualifications:
2 years+ experience as administrative assistant within a nutraceutical/food/science related or similar organizationTwo-year degree in technical degree in a related field (i.e. chemistry, technology, or business)IT savvy with new programs and experience with Microsoft Office, especially MS ExcelDetail oriented with high organizational skills, and prioritization of tasks or projectsExcellent verbal and written communication skills, problem solving, team building and interpersonal skillsHighly analytical and able to evaluate, analyze, and summarize large volumes of data and technical material efficiently such as lab reports, specifications and operational recordsKnowledgeable of administrative and clerical procedures and systems such as managing files and records, designing forms and other office dutiesMust be knowledgeable in cGMP requirements and familiar with the concept of Quality programsMust be a self-directed individual who works under minimal supervisionMust be knowledgeable and compliant with all IVC company policies and SOP/WIsMust maintain document compliance with FDA and foreign Regulations/GuidelinesMust be acquainted with and adhere to country specific regulations governing document preparation