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Job #03535

About our client Our client is a market leading pharmaceutical company headquartered in Europe that is focused on the commercialization of high quality diagnostic agents. The company has an excellent reputation, a growing revenue stream and a deep pipeline of products in development. This is a strong opportunity for an experienced Regulatory professional that wants to put their drive and initiative to work! Position Location Compliance Manager Indiana Salary Highly competitive package, commensurate with experience Responsibilities 1) Direct local regulatory, quality, clinical and pharmacovigilence policies, objectives and initiatives. 2) Review and validate regulatory submissions, annual reports and correspondence in collaboration with HQ. 3) Establish regulatory and quality procedures based on current regulations. 4) Review procedures, instructions, labels, promotional/collateral material to ensure compliance with applicable regulations. 5) Provide regulation and product guidance to customers and employees. 6) Frequent partnership with corporate Quality and Regulatory Affairs departments. 7) Interacts with government agencies, consultants and partners. 8) Monitor and maintain SISPQ of products on market. 9) Manage clinical trials, develop associated protocols/reports, and review scientific data prior to publication in collaboration with HQ. 10) Manage local pharmacovigilence. 11) Develop and maintain regulatory knowledge of US regulations. 12) Lead and direct the work of others to accomplish department objectives. 13) Responsible for the attainment of short- and long-term department goals. Requirements 1) At least four years relevant pharmaceutical experience and demonstrated effective interaction with regulatory authorities. 2) Bachelor’s of Science degree. 3) Must have broad US regulatory knowledge in drug or device development. 4) Must be skilled in strategic planning/execution; risk management. 5) Strong attention to detail and communication/interpersonal skills. 6) Excellent planning/organizational skills. 7) Global perspective.