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For your reference, we have included the original job posting below.
Regulatory Affairs Specialist
Job Number:
25079662
Company Name:
Kemin Industries, Inc.
Job Location:
Des Moines, IA US
Job Category:
Healthcare & Medical
Regulatory Affairs Specialist
Regulatory Affairs Specialist
Job ID: 2010-1023 # Positions: 1
Location: US-Des Moines Posted Date: 5/27/2010
Category: Research & Development
More information about this job:
Overview :
The RA Specialist 2 provides support for KH’s national and international product registrations, supports the RA department to ensure regulatory compliance of product formulations, labels, and literature and Intellectual Property portfolio. The position also involves significant customer support providing RA-related materials and answering customer inquiries.
Responsibilities :
* Provide significant contributions to the document control procedures and practices, and change control procedures within the company with tracking of RA related document reviews and change management activities as necessary. * Act as Coordinator for KH RA’s customer inquiry system and respond to customer inquiries. * Manage product formulas in M3 ERP system, as well as coordinate M3 product formula entry process and maintain product formula documents. * Create and maintain RA-related product-specific documents such as labels, substantiation information as applicable, and RA collateral. * Organize and maintain RA generated documentation, library, and subscriptions as necessary. * Maintain current, or obtain as necessary, KH production licenses, e.g. PACA, food processing license in compliance with State and Federal regulations and track renewal dates. * Coordinate and participate in product certification audits, e.g. Kosher, Halal. * Prepare routine registration dossier drafts, such as Kosher and Halal, and assist in preparing moderately complex submissions to gain registrations, and maintain product registration files. * Proof-read, edit, format, and redact regulatory documents and submissions as necessary. * Conduct some regulatory research, including locating international regulations. * Attend industry trade shows and training courses to stay current on relevant regulations. Also independently complete regulatory reading of existing, as well as new, regulatory requirements as necessary.
Qualifications :
* Undergraduate degree with 1-3 years experience or an Associate degree with 3-5 years experience, degree in science or regulatory affairs preferred. * The successful candidate will be detail-oriented, organized, reliable, self-motivated, and will interact well in a team environment. Ideally, this candidate will have some database management experience and proficient written communication skills. * Excellent organizational skills required. * Excellent attention to detail required. * Must also possess excellent time management, and both written and oral communication. * A good understanding of the chemical and biological sciences and the commercial application of such science-based technologies is desired. * A good understanding of business processes, knowledge of food GMPs and the fundamentals of auditing is desired. * Must be able to handle multiple assignments concurrently, capacity to produce high quality results across multiple projects while working under time lines. * Ability to work independently as well as a team player. * A high degree of personal motivation along with a desire to make an immediate contribution (sense of urgency). * Must be customer service-oriented and work well with varied personalities inside and outside of the corporation. A high degree of professionalism is required. * Strong communication skills with minimum English Speaking Ability of Advanced Mid as defined in the ACTFL Proficiency Guidelines. * Must possess advanced PC and MS Office skills. * Some database management experience is desired, but not required. Decision Making & Freedom to Act: The RA Specialist 2 reports directly to the RA manager and is involved in ongoing administrative tasks in support of the RA team. Kemin believes in allowing its employees the freedom to make decisions and action them in accordance with their ability and level of reporting.
Working Conditions: The RA Specialist 2 is based at the Kemin Health headquarters in Des Moines, Iowa. The position is considered to be 40 hours per week, but requires some flexibility.
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