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 #02772 About our client Our client is a leading pharmaceutical company headquartered in California that is focused on the development and commercialization of various ophthalmology disease therapeutics. The company has 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 Regulatory Affairs Operations Specialist I Irvine, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide administrative support for the creation and editing of regulatory submissions and technical documents 2) Oversee formatting, proofreading, publishing and printing of documents that are scheduled for government submissions (INDs, NDAs, DDMAC filings, MAAs) as well as other related word-processing requests 3) Package, track and process documentation for submissions sent to regulatory agencies (FDA, EMEA, etc.) 4) Ensure that all regulatory documents associated (paper and electronic) are identified, organized and maintained to be easily retrieved in the Central Archive Room and fileserver (required by regulations or SOPs) 5) Ensure record filing and record data entry is kept up-to-date and performed accurately 6) Maintain the check-in/check-out system for the paper archive and perform audits to verify integrity 7) Track all regulatory submissions, contacts and correspondence in the regulatory archive database 8) Maintain a working knowledge of regulatory documents to assist with searches and retrievals 9) Coordinate on- and off-site transfer as well as storage and retrieval of records 10) Prepare final copies of regulatory submissions for dissemination to regulatory authorities or other required parties 11) Review submission documents for formatting issues to ensure high quality 12) Perform bookmarking and hyperlinking (required for electronic submission) 13) Compile paper submissions, including tabs, labels, shipping, etc. 14) Ensure compliance with company-style templates 15) Assist in the development and drafting of departmental written procedures that govern regulatory processes 16) Work closely with Regulatory personnel (as necessary) to ensure receipt of complete and orderly regulatory documentation for archiving 17) Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the FDA and ICH 18) Make decisions within generally defined practices and policies, in selecting methods and techniques for obtaining solutions Requirements 1) BA/AA degree or equivalent experience in regulatory operations/archiving/related field 2) Up to 2 years of experience in using ISI Toolbox and other electronic publishing software 3) Knowledge of Adobe Acrobat and other software used in developing electronic regulatory submissions 4) Excellent MS Office skills (advanced features such as macros, templates, style usage and automated aspects and standard tools) 5) Superb interpersonal and time-management skills 6) Demonstrated ability to identify issues and take initiative to recommend solutions 7) Ability to master new technical skills and apply them to projects (as needed) 8) Self-starter with ability to work independently or in teams 9) Flexible to work on issues of diverse scope and apply the knowledge gained in multiple tasks 10) Ability to balance multiple routine tasks simultaneously to achieve goals and satisfy customers 11) Ability to work well with minimal supervision and procedures (undefined) and guidelines 12) Ability to maintain confidential information related to the organization 13) Excellent communication (verbal and written) skills
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