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About our client
Our client is a biopharmaceutical company focused on the development, manufacture, and commercialization of biopharmaceutical products such as vaccines and immune globulins that induce the body's immune system to prevent or treat disease. The company operates in two business segments: biodefense and commercial. In its biodefense business the company develops and commercializes immunobiotics for use against biological agents that are potential biological weapons. In its commercial business, the company develops immunobiotics for use against infectious diseases with significant unmet or underserved medical needs.
Position	Location
Regulatory Affairs Manager	Maryland
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Serve as the regulatory representative for product development teams 2) Provide regulatory support and advice for the teams 3) Facilitate regulatory strategy development and implementation for product development teams 4) Lead regulatory submissions for products 5) Write, review, and coordinate quality submissions to regulatory agencies 6) Prepare for meetings, teleconferences, and other communications with FDA (including read-ahead packages and/or other necessary documentations) 7) Educate teams regarding regulatory risks and implications for strategy and product development activities 8) Utilize technical knowledge and apply regulations and guidelines to the product development process
Requirements
1) Master’s degree or Ph.D. 2) 5-7 years’ experience in regulatory affairs in biologics 3) Hands-on experience in blood products or vaccines