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Job #03387

About our client Our client, a biopharmaceutical company, focuses on developing therapeutic products, for the medical needs of patients with debilitating conditions and life-threatening diseases. With numerous revolutionary products in the development and pre-clinical development stage, this is a great opportunity for someone to join a company which offers a great corporate culture and is focused on the long-term development of its employees. Position Location Director of Regulatory Affairs and Compliance Georgia Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead and manage a highly active and successful international Regulatory and Compliance Group 2) Oversee global regulatory submissions such as US and European Drug Master Files (DMFs), Certificates of Suitability (COS), DMF amendments, annual reports and supplements 3) Prepare and manage API technical packages submitted to customers 4) Conduct routine GMP inspections 5) Prepare for and attend FDA inspections and customer GMP audits of the company’s international API suppliers (primarily in India) 6) Respond to any deficiencies resulting from an inspection Requirements 1) Bachelor's degree or higher in a scientifically-related field 2) Minimum 5 years of experience in pharmaceutical regulatory affairs and compliance 3) Prior managerial experience 4) Working knowledge of regulatory, GMP compliance and FDA regulations along with applicable laws 5) Ability to interact effectively with other business units including Sales and R&D to coordinate as well as accomplish customer and FDA needs 6) Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals and technical procedures 7) Ability to write routine reports and business correspondence as well as develop effective global internal/external relationships 8) Willingness to travel internationally, primarily to India (up to 30%)