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 #02771 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 Specialist IV Irvine, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan and prepare new drug submission for FDA and other international agencies 2) Assist in supporting the process of meeting requirements established by US and international governmental agencies in introducing new drug products to market 3) Act as the lead in developing sections of US and international submissions 4) Resolve submission problems independently 5) Provide support to currently marketed products (as necessary) 6) Perform independent reviews and approve labeling of currently marketed products, including promotional materials, product changes and documentation for changes requiring governmental approval 7) Assist in preparing periodic reports for FDA and other similar international agencies (as required by product status) 8) Maintain current knowledge of worldwide drug regulatory requirements 9) Interface with appropriate governmental agencies on project/products (as identified by the Supervisor) 10) Support Regulatory Affairs by generating documentation required for FDA and EMEA (e.g. NDAs, INDs, Amendments and Supplements) 11) Oversee the junior regulatory specialists (as required by the project) 12) Document and summarize test results accurately 13) Review and approve (independently) manufacturing-related protocols and evaluation of technical data 14) Monitor the drug project history file for completeness and accuracy 15) Review and approve (independently) clinical protocols as well as evaluate the clinical data 16) Participate and/or lead drug product development teams (as assigned) 17) Evaluate technical issues and make initial recommendations for possible corrective actions to the Director 18) Complete projects in an assertive manner consistent with corporate objectives 19) Communicate (proactively) the project status to the Supervisor 20) Provide regulatory guidance and training to all employees 21) Support company goals and objectives as well as policies and procedures (GMPs, FDA drug regulations and guidance with international drug regulations like MCA, MDD and EMEA) 22) Maintain a professional and credible image with FDA and other regulatory agencies, consultants, vendors, customers and co-workers 23) Perform all other duties as assigned Requirements 1) Bachelor’s degree in Chemistry, Microbiology or a scientific discipline with minimum 10 years of regulatory affairs experience in the pharmaceutical or biotechnology industry/Master’s degree with minimum 8 years of regulatory affairs experience in the pharmaceutical/biotechnology industry/Ph. D. with minimum 5 years of regulatory affairs experience in the pharmaceutical or biotechnology industry) 2) Experience in IND, NDA and DDMAC submissions 3) In-depth knowledge of US and international drug regulations (GMPs, GCPs, GLPs, ICH guidance documents) environment 4) Experience in an R&D, manufacturing, laboratory and quality systems 5) Superb knowledge of advertising, promotional and labeling regulations 6) Good knowledge of research and creating research papers 7) Ability to strategically interpret and communicate regulatory requirements (as required)
Home | Our Story | Domain Expertise | Clients | Career Opportunities | Community | Contact Us
© 2006 Sterling Life Sciences. All rights reserved. Terms of Agreement.