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Job #03377

About our client Our client is a global pharmaceutical company headquartered in New York. They lead the market with filtration, separation and purification products being their specialization. The company has an experienced management team, an unmatched product portfolio and an empowering corporate culture that is focused on the long-term professional development of it's employees. Position Location Senior Director of Regulatory Affairs Port Washington, New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Liaise with the FDA and interact directly with other global health authorities 2) Ensure the compilation of regulatory dossiers that meet agreed timelines (personally or through subordinate staff) 3) Create, prepare, execute and assist in supportive strategies for products to be successfully registered in global markets (e.g. European system as a part of EEC technical file applications, Japanese PAL for MOLHW) 4) Work closely with the company’s Global Regulatory personnel to harmonize these systems 5) Oversee the maintenance of submission correspondence and other regulatory files in a complete as well as secure manner 6) Create project deliverables aligned with appropriate internal and external guidance documents 7) Provide regulatory input in scientific quality assessments and product development systems 8) Review and approve test protocols to support regulatory submissions 9) Establish global bio-compatibility testing standards 10) Provide project, departmental and company guidance/training based on current as well as emerging regulatory policies 11) Establish regulatory requirement for shelf-life studies for product submissions and a Part 11 compliant electronic product submission system Requirements 1) Ph. D./J. D. 2) Minimum 10 years of experience in a regulatory affairs environment in device/biologic/biotechnology/pharmaceutical/tissue therapy industries 3) Minimum 10 years of global personnel experience 4) FDA experience (specifically with the CBER Division) 5) Experience in blood and cell therapies 6) Strong knowledge of FDA regulations specific to the areas of clinical research, electronic submissions and document dossiers 7) Exceptional communication skills (written and oral)