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Job #03526

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 Director of Regulatory Affairs Michigan Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee all regulatory activities required for routine lot release 2) Plan and execute required regulatory filings to maintain product license and establishment registration 3) Plan and execute key regulatory filings in support of various manufacturing changes to enhance cGMP compliance, production capacity and product improvement 4) Support international licensing activities and oversees implementation of foreign registration requirements at the facility 5) Provide regulatory guidance to site functional groups regarding all aspects of manufacturing and operational activities 6) Provide regulatory support to new product development activities at the manufacturing facility 7) Utilize technical knowledge and effectively apply regulations and guidelines to regulatory filings, and provide authoring, review, and coordination for quality submissions 8) Serve as regulatory liaison to the FDA and other regulatory authorities for assigned projects 9) Prepare and communicate regulatory risk assessment to the project teams and senior management 10) Manage the Michigan regulatory group and departmental budget Requirements 1) 12 plus years of industry experience in Regulatory Affairs for licensed biological products and biologics in advanced development 2) Masters Degree in related biological and life science field required. PhD preferred