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 #02542 About our client Our client is a publicly traded pharmaceutical company headquartered in Southern California that is dedicated to the development and commercialization of generic therapeutics for the treatment of various diseases. The company has an excellent track record with regulatory agencies, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees. Position Location Regulatory Affairs Manager California Salary Highly competitive package, commensurate with experience Responsibilities 1) Formulate regulatory strategy and tactics for appropriate regulatory submissions (e.g. ANDAs, dossiers, amendments and supplements) for domestic, international and/or contract projects 2) Coordinate, prepare and review all regulatory submission within specific time frame and in conjunction with the organization 3) Provide project management support to labeling specialist in developing/reviewing of draft and final printed product labeling 4) Coordinate and review development of promotional labeling with marketing 5) Communicate as the Regulatory Affairs person with FDA, business units, contract customers and international customers as assigned 6) Coordinate and review for submitting bi-annual drug listing with Regulatory Labeling Specialist 7) Review and analyze regulatory and related publications to ensure compliance and anticipate future regulatory actions both internally and externally Requirements 1) Bachelor’s degree (scientific/healthcare discipline/equivalent combination of education and related experience) preferred 2) Minimum 5 years of pharmaceutical industry experience 3) 4+ years of experience in pharmaceutical (drug) regulatory affairs 4) Experience as lead RA person on a NDA & ANDA submission 5) RAC certification a plus 6) Working knowledge of CMC 7) High-level understanding of ICH and FDA guidelines 8) Proficiency in electronic document-management and electronic submissions 9) Ability to formulate regulatory strategy and tactics (e.g. legal, labeling, clinical, filing etc.) to support filing of a regulatory submission 10) Demonstrated ability to work in a team environment 11) Excellent oral and written communication skills
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