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 #02509 About our client Our client, a biopharmaceutical company, focuses on developing therapeutic products, for the medical needs of patients with debilitating conditions and life threatening diseases. The programmes of the company are intended for gastroenterology as well as treating HIV infection and cancer. The company has many products in the development and pre-clinical development stage. Position Location Regulatory Affairs Manager New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Generate documentation to support and execute RA plans 2) Work closely with Manufacturing, Scientific and Quality personnel 3) Support the preparation of CMC regulatory submissions (INDs, CTAs, master files and their amendments) 4) Write, review and edit technical reports and regulatory documents 5) Coordinate and ensure effective and timely input into the planning, agreement and generation of required CMC documentation 6) Ensure effective review and compilation of dossiers for submission from matrix teams 7) Participate in discussions with FDA and/or health authorities 8) Handle all activities related to writing and finalization of CMC sections of briefing books (when necessary) 9) Participate in project teams 10) Exercise expertise and judgment in providing guidance to other personnel on CMC issues 11) Liaise between company’s technical areas and external consultants 12) Keep abreast of biologics CMC requirements for antibodies, vaccines and gene therapy Requirements 1) MS or BS degree with 5-7 years of experience in the field of biotechnology, analytical/ pharmaceutical technology 2) Minimum 2 years of practical experience in regulatory affairs or related regulatory environment in biologics/biotech field preferred 3) Experience in clinical development requirements for cancer, HIV products and NDA/BLA preparation preferred 4) Thorough understanding of biologics/biotech product development 5) Solid working knowledge of cGMPs and CMC affairs in biologics/biotech field preferred 6) Ability to critically evaluate data from a broad range of scientific disciplines 7) Thorough understanding of the regulatory requirements for CMC filings in the US and Europe 8) Strong negotiation skills 9) Superb communication (verbal, written, listening) and interpersonal skills 10) Strong background in writing and editing technical reports and investigations with demonstrated ability to interact with multi-disciplined teams 11) Ability to communicate across multiple disciplines successfully and accurately (both internally and externally) 12) Superb attention to details and accuracy 13) Ability to adapt to changing priorities 14) Excellent knowledge of the English language
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