Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02824 About our client Our client is a leading pharmaceutical company specialized in pain therapy. They have close to 5,000 employees globally and have a developed a reputation as a leading innovator in the field. With operations in approximately 30 countries and a 70-year track record of success, this is a great situation for a candidate that is pursuing a challenging opportunity with a world-class employer. Position Location Regulatory Affairs Supervisor New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Act as lieutenant to Director of Regulatory and Safety Affairs 2) Represent the RA Department in internal and external meetings (if there are schedule conflicts or in the absence of the Director of Regulatory and Safety Affairs) 3) Provide recommendations and advice to the internal customers on the regulatory aspects of development as well as registration of products in the US 4) Assist with preparing and submitting IND applications 5) Lead Regulatory Affairs staff in constructing and submitting updates to INDs including investigational brochures, annual reports as well as briefing books for FDA meetings 6) Interact with Director of Regulatory and Safety Affairs and regulatory staff at company headquarters, to streamline procedures for submission coordination and documentation 7) Work with Director of Regulatory and Safety Affairs to report SAEs to regulatory authorities (as required) 8) Work with US Regulatory Affairs to build regulatory infrastructure, SOP documentation methods and forms 9) Interact with US Regulatory Affairs to develop optimal methods of interacting with other departments and consultant networks 10) Review and contribute to regulatory strategy documents 11) Assist with planning and preparation of market applications in CTD format 12) Attend agency meetings (as required) 13) Provide training in US regulatory affairs 14) Maintain current regulatory affairs and technical knowledge through review of FDA website, trade newsletters, scientific publications, etc. 15) Provide QC services on project documents written by colleagues Requirements 1) Bachelor's degree in a scientific discipline 2) Minimum 3 years of regulatory affairs experience in drug development (except medical devices) 3) Experience in analgesics/anesthetics and immunology/oncology therapeutic areas preferred 4) CDER experience preferred 5) Experience in preparing regulatory documents for submission (IB, annual reports, etc.) independently 6) Understanding of scientific rationales and logic in drug development 7) Knowledge of appropriate US and ICH guidelines as well as development regulations 8) Experience in attending FDA meetings 9) Excellent communication skills (verbal and written)
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