Xiromed-Senior Regulatory Associate - (Florham Park, NJ)

Title: Associate/Senior Associate, Regulatory Affairs (Xiromed) Reports to: Senior Manager, Regulatory Affairs (Xiromed) This position is for Xiromed, an affiliate of Exeltis, USA . For more info about Xiromed, visit: Primary Duties and Responsibilities Author Module one and Product Quality sections for regulatory filings to US and International Health Authorities for new drug development and approved products. Coordinate with external vendors such as Contract Manufacturing Organizations and Development Partners for new product development and provide regulatory strategy and guidance to comply with US FDA qualifications. Coordinate with Clinical Research Organizations for Bio-equivalence and/or vehicle studies in humans and compile Module five section in ANDAs/505b2 NDAs. Submit Controlled Correspondence requests and Citizen Petitions as needed. Participates in meetings with cross functional teams and and external customers and provide regulatory strategy and guidance.