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Job #03449

About our client Our client is dedicated to the development of diagnostic and therapeutic radiopharmaceuticals for use in rare diseases. The company's vision is to transfer technologies to those most in need. The company's subtle leadership has resulted in four initial products or chemical entities in various stages of development or under licensing discussions at this time. The company's goal is to elucidate opportunities that will enable the diagnosis and treatment of rare diseases that will be designated as Orphan Drugs. Position Location VP Quality and Regulatory Affairs Indiana Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the submission of an ANDA to the US FDA and Health Canada 2) Responsible for overseeing all quality audits, etc, for the contract manufacturing of the product Requirements 1) Experience with ANDA or generic, DMF, FDA, Health Canada and Quality Audits