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 #02776 About our client Our client is a leading pharmaceutical company headquartered in California that is focused on the development and commercialization of various ophthalmology diseases 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 IV Irvine, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Work with regulatory document authors to achieve resolution 2) Ensure that documents comply with regulatory and company guidance/template specifications 3) Work with all departments (R&D, Regulatory Affairs, Quality Assurance, etc.) to implement processes and QC checks to ensure that all regulatory submission information is accurate, complete and meets regulatory document specifications 4) Lead the validation process for any upgrades to the currently validated regulatory publishing system 5) Work with IT and the vendors to manage the validation of systems in a timely manner 6) Create and compile quality global regulatory submissions as well as lifecycle management submissions 7) Facilitate the development of electronic systems 8) Plan, prepare, track and archive regulatory documents and submissions in paper and electronic formats 9) Ensure that process for submission of regulatory document is performed in accordance with established procedures 10) Plan and prepare regulatory submissions to FDA and other regulatory agencies using paper and/or electronic publishing tools 11) Execute the daily activities involved in the preparation, QA and assembly processes of submissions 12) Manage official regulatory files in paper and electronic form 13) Receive and organize component documents from paper and/or electronic sources 14) Support various task force activities related to new applications and supplements 15) Create and maintain tracking systems for component pieces of submissions 16) Ensure conformance with regulatory requirements, guidelines, internal standards and timelines 17) Establish and implement processes for departmental SOPs as well as the generation of electronic submission-ready documents 18) Develop training materials 19) Provide training and technical/document support to internal disciplines and external contractors 20) Maintain the Regulatory Archive Database layout updates, changes and upgrades 21) Liaise with external vendors in support of regulatory submissions 22) Maintain working knowledge of regulations and processes that govern the content and maintenance of controlled documents required by the FDA and ICH Requirements 1) Bachelor’s degree or demonstrated industry experience 2) 5 – 10 years of experience in the pharmaceutical industry 3) Experience in regulatory documentation (authoring, reviewing, QC or auditing) 4) Experience in working effectively in cross-functional teams 5) Knowledge of IND, NDA, MAA, CTD requirements and guidelines, both paper and electronic 6) Strong technical knowledge of electronic publishing systems and software 7) In-depth understanding of quality standards for regulatory documents 8) Proficiency with MS Office and Adobe Acrobat applications 9) Ability to work under strict deadlines and changing priorities with minimal supervision on routine assignments 10) Ability to work independently or in teams 11) Ability to effectively manage resources to achieve business objectives 12) Self-starter with excellent time-management skills 13) Superb organizational skills 14) Detail-oriented
Home | Our Story | Domain Expertise | Clients | Career Opportunities | Community | Contact Us
© 2006 Sterling Life Sciences. All rights reserved. Terms of Agreement.