Manager Of Regulatory Affairs Jobs in Iowa

Job Title: Regulatory Affairs Manager Company: Kemin Health Location: Des Moines, IA Description: Overall Function: The RA manager provides regulatory support for KH existing products and the new product development process to ensure compliances with regulatory requirements. This individual is involved in developing and implementing regulatory strategies, and supporting national and international product registrations. The position will also be responsible for maintaining product registration approvals by ensuring compliance with legal requirements and implementing post-approval changes required. Major Responsibilities: Focus and prioritize activities of assigned projects and assume responsibility for their success Understand regulatory requirements and relevant government regulations for KH products, as well as stay current on regulatory issues affecting KH products, and recommend necessary adaptations; some work managing outside legal counsel and consultants on the same Work with the global regulatory team in implementing the regulatory strategy to achieve timely filing and approval of new and existing products for international markets in accordance with business objectives Conduct regulatory research, including locating regulations and some analysis of regulatory items or issues, including international regulations, and effectively communicate pre-submission strategy/regulatory pathway and testing requirements for successful regulatory submissions with other functional groups Assist with complex regulatory submissions, and prepare product registration dossiers to obtain and maintain global regulatory approvals for Kemin products under supervision Serve as RA liason in Kemin's new product development process, research and development of regulatory plans in conjunction with new product development and introduction; conducting regulatory evaluations of scientific evidence for substantiating the efficacy and safety of the Kemin products; Provide regulatory guidance and direction in the design and execution of clinical and safety studies in compliance with regulatory requirements to support the safety and marketing claims of new and existing products Assist in the review of product information including but limited to product specifications, formulas, labels, MSDS, marketing/sales literature, labeling and advertising materials for compliance, analyze and recommend appropriate changes NOTES: US Residents Only