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Job #03528

About our client Our client is a publicly traded biopharmaceutical company headquartered in Maryland which is focused in the development and commercialization of vaccines and treatments to help the immune system prevent diseases. The company has an experienced management team, a robust pipeline of products and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Sr. Manager, Regulatory Affairs Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in developing regulatory strategy and oversees its integration to the overall product development plan and effective implementation 2) Provides guidance on FDA requirements regarding all aspects of product development and timing, logistics and operational recommendations 3) Utilize technical knowledge and effectively apply regulations and guidelines to the product development process 4) Develop regulatory submission strategies in agreement with product development objectives, and manages regulatory submission strategies 5) Provide authoring, review, and coordination for quality submissions to regulatory agencies 6) Serves as regulatory liaison to the FDA and other regulatory authorities for assigned projects 7) Will also prepare for Agency meetings, teleconferences, and other communications with regulatory agencies 8) Prepare risk assessment for regulated aspects of product development, and communicates risks, impacts and mitigations to the project teams and senior management Requirements 1) 5+ years of industry experience in Regulatory Affairs for products in advanced development (IND to BLA) 2) Regulatory affairs experience in biologics 3) Advanced Degree (MS or PhD preferred) in related biological and life science field 4) Vaccine, monoclonal antibody or polyclonal antibody experience preferred