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Job #02951

About our client Our client is a privately held biopharmaceutical company focused on the treatment of vascular disease. Position Location Senior Regulatory Affairs Manager Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead and work closely with Regulatory and other senior management to develop company-wide programs and processes for strategic planning as well as implementing submissions for new and modified products 2) Develop effective regulatory strategies to meet business objectives 3) Educate, train, advise and coach regulatory and other company professionals on the regulations, procedures and processes relevant to product registration submissions 4) Liaise with internal personnel and external regulatory bodies to ensure appropriate input into regulatory strategies 5) Work with Quality to ensure appropriate auditing for compliance and consistency 6) Identify, assess and proactively manage regulatory risk 7) Lead and support continuous improvement activities within areas of assigned duties Requirements 1) Bachelor’s degree (Advanced degree preferred) 2) Minimum 3 years of experience in regulatory affairs 3) Experience in managing overseas staff in foreign offices (India preferred)