Regulatory Labeling Associate
KV Pharmaceutical (St Louis, Missouri)

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Position Description:

Regulatory Labeling Associate KV Pharmaceutical seeks a Regulatory Labeling Associate. The successful candidate will ensure the integrity and accuracy of labeling for all finished drug products and raw materials. You will also be responsible for ensuring the accuracy and integrity of all advertising and promotional materials and drug product information posted on Company web sites. The incumbent will provide assistance to Regulatory Affairs Associates in the generation, review and submission of product labeling to FDA for new drug product submissions, amendments and supplements as well as provide assistance to International Regulatory Associates in the generation, review and submission of product labeling to global regulatory authorities. You will maintain departmental labeling review files for marketed products and provide guidance to marketing groups for development of promotional materials and studies designed to support additional labeling claims and promotional aids. The ideal candidate will have a Bachelor’s degree, preferably in pharmaceutical or natural sciences, or equivalent experience with pharmaceutical quality assurance, or regulatory compliance. Minimum three years experience in generation, review and approval of drug product labeling is required. If you have experience with generation, review and approval of advertising and promotional materials apply today. Experience with electronic regulatory submissions is desired. The successful candidate will possess expert knowledge of FDA/FTC regulations pertaining to drug product labeling, exceptional proofreading skills and attention to detail. We are seeking individuals who possess excellent verbal and written communication skills, offers an organized approach to providing timely accurate reports, can multi-task, prioritize, and is proficient in Microsoft Office. KV Pharmaceutical Company, a dynamically growing organization, (www.kvph.com) has reported its 12th consecutive year of record revenues in Fiscal 2007, reporting net sales of over $440 million. KV is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technologically distinguished products through Ther-Rx Corporation, our branded wholly-owned subsidiary and ETHEX Corporation, our generic/non-branded wholly-owned subsidiary. With more than 60 years in business, KV applies its 15 unique patent protected and proprietary drug delivery technologies to both the brand and generic/non-branded subsidiaries. Based in St. Louis, Missouri, St. Louis is One of Forbes’ “200 Best Metropolitan Areas” in America in 2006. St. Louis was also named the second most affordable large metropolitan area in the country by the National Association of Home Builders in 2005. St. Louis offers a world-class medical community with over 50 general practice, teaching and research hospitals including Washington University and St. Louis University. St. Louis is also rich in education with more than a dozen nationally-recognized four-year universities. KV Pharmaceutical (NYSE: KVa/KVb) provides a comprehensive benefits package including a 401(k) and profit-sharing, health, vision, and dental. We offer competitive salaries and stock options for many positions which have proven to be lucrative to many long-term KV employees. EOE M/F/D/V

To Apply Visit KV Pharmaceutical