Job Description
KV Pharmaceutical is seeking a Regulatory Affairs Manager for its branded subsidiary, Ther-Rx. As a Regulatory Affairs Manager, you will have responsibility for the support the execution of branded global projects. You will align with departmental goals, objectives and metrics and may provide scientific and regulatory technical input in one or more of the following areas; preclinical research, toxicology, chemistry, manufacturing, clinical trials, or product development support. The successful candidate may serve as regulatory representative or support to assigned regulatory representative on project teams. Implement regulatory strategies for internal programs. Key responsibility is the preparation of submissions including - INDs, CTAs, NDAs, MAAs, amendments, supplements, etc.
The incumbent will interact with internal and/or external clients. Identifies and communicates issues and problems appropriately to management, work effectively with little direction from management, identify project needs, creates project timelines for multiple projects, serve as Regulatory Representative or technical lead for project teams, maintain effective relationships between other KV business departments or functions, internal and external "clients", regulatory agencies, and other constituents. We are seeking an individual who can manage fiduciary, physical and intangible assets and who can promote corporate values and advocates actions that create a work environment that attracts and retains the best people. If you can demonstrate knowledge of regulatory (branded) processes and practices, governmental agency regulations and requirements affecting the business unit or functions, provide support for global regulatory filings under supervision of senior staff members, and provide management on status and progress of submissions and submission strategy apply today. We are seeking a candidate who has working knowledge of regulatory requirements who can support Evaluation and interpretation of applicable FDA regulations and guidance's and prepare written regulatory opinions or regulatory positions. You will coordinate IND, CTA, NDA, MAA submissions globally and assure timely preparation of all regulatory required reports for maintenance of assigned INDs and NDAs.
The successful candidate will preferably have a Ph.D and RAC certification preferred. You must have the ability to exercise sound judgment in developing methods, techniques, and evaluation criteria for obtaining positive results in a regulated environment, demonstrate collaboration with others and provide independent thought to improve processes for project and department operations (Work Instructions / SOPs), and have good working knowledge of regulations relevant to the area of expertise. If you can work on several projects at once while balancing multiple timelines (i.e., overlapping timelines on one or more projects), can assess workload and prioritize, and have the ability to make oneself understood at all levels in the organization; behaves professionally and remains effective in difficult and stressful situations apply today. We are seeking individuals who are detail-oriented, possess excellent verbal and written communication skills, math skills, offer an organized approach to providing timely accurate reports, and are proficient in Microsoft Office.
With 13 years of record revenues, KV Pharmaceutical Company (www.kvph.com), a high-growth organization, has reported year-over-year net sales of 35.7% to over $600 million for Fiscal Year 2008.
KV Pharmaceutical (NYSE: KVa/KVb), is a fully integrated specialty pharmaceutical company that develops, manufactures, markets and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology-distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its emerging branded drug subsidiary. With more than 65 years in business, KV applies its 15 unique patent protected and proprietary drug delivery technologies to both the brand and generic/non-branded products.
KV is based in St. Louis, Missouri, which was recently named as a 2008 All-America City by the American City Business Journals, 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 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.
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