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 #02535 About our client Our client is a company dealing in the biopharmaceutical sector, developing novel gene-based therapeutic drugs and vaccines. These products help in the production of proteins directly at the site of disease by the genes it delivers. All gene-based therapies use the same patent protected technology. Position Location Regulatory Affairs Associate Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide regulatory assistance for the veterinary/vaccines biologics project 2) Ensure the coordination and preparation of regulatory submissions 3) Prepare document packages required for IND, NIH/OBA, Master Files, BLA, CVB applications and other regulatory submissions 4) Maintain INDs and NIH filings, including annual updates, amendments, SAE reporting and manufacturing information etc. 5) Assist with CVB permit applications and licensing requirements (e.g., Summary Information Format (SIF), Outline of Production) 6) Prepare quality regulatory submissions (9CFR and 21CFR) 7) Assist with document control, regulatory compliance (cGMP, GLP, and GCP) and provide guidance with regard to CMC/manufacturing and Clinical issues 8) Review technical data/reports in support of applications 9) Write SOPs and other process documents 10) Provide regulatory support to customers, collaborators and partners 11) Perform other responsibilities as required for the position and the team Requirements 1) Bachelor’s degree in Biology/Molecular Biology/Science or a related field 2) 1-3 years of industry experience 3) Experience in vaccines/gene therapy and with Center for Veterinary Biologics (CVB) preferred 4) Thorough working knowledge of FDA regulations and submission procedures 5) Experience with gene therapy, animal biologics and/or biologic CMC manufacturing a plus 6) Experience in FDA training on regulations and submission procedures 7) Experience in training on technical document review 8) Hands-on computer skills (Microsoft Office suite skills – basic, but training may be provided to enhance skills through company’s in-house training program, but candidate must have working knowledge of this software) 9) Excellent time-management skills 10) Excellent interpersonal, written, verbal and administrative skills 11) Good written and oral communication skills 12) Willingness to work in a dynamic goal-oriented environment
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