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 #02507 About our client Our client is a leading privately held pharmaceutical company with operations in over 40 countries. With marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! Position Location Director of Regulatory Affairs New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Work closely with Management, Operations, Sales and Marketing, outside contractors, and other divisions of the company and the FDA 2) Liaise with FDA, as necessary, including arranging and attending face-to-face meetings 3) Advice on regulatory strategy and tactics and follow through to implementation, submission and approval 4) Prepare periodic reports to FDA (annual reports, safety reports, etc.) 5) Conduct label review and submit to FDA 6) Investigate new drug applications 7) Ensure compliance with CGMPs and CGLPs 8) Advertise and promote review for compliance with FDA regulations and guidelines 9) Understand the process of development and marketing of a drug or drug/device combination 10) Develop formulation (i.e. development reports’ specifications, analytic techniques and validation) 11) Maintain stability 12) Conduct transfer of technology to manufacturing/operations for supplies and commercial production 13) Oversee clinical and pre-clinical development 14) Support preparation of regulatory submissions as required 15) Assist contractors on compliance with CGMP, CGLP and pre-approval inspections 16) Support research and regulatory projects as assigned Requirements 1) M.S. or Ph. D. in relevant Science or Pharm. D. 2) 8-15 years of experience in regulatory affairs (including FDA liaison, product development and project management) 3) Experience as a primary FDA liaison on device submissions (both PMA & 510k) 4) Experience in regulation of devices e a plus 5) Excellent written and communication skills 6) Ability to interface well with management, marketing and sales, outside contractors and FDA 7) Excellent computer skills (i.e. Word, Excel, PowerPoint, Microsoft Project, graphics and graphing programs) 8) Ability to multitask effectively and handle pressure 9) Willingness to travel
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