Regulatory Affairs Specialist
Our client, a Fortune 50 company and Leader in the Pharmaceutical industry seeks a talented Regulatory Affairs Specialist to work on electronic Drug Master File (DMF) and Chemistry, Manufacturing and Controls (CMC) submissions.
B.A./B.S. degree; Regulatory Affairs certification preferred
Good understanding of scope and requirements and experience with CMC/DMF regulatory submissions
Good communication skills and proven organizational skills
Azzur Group is a private company and comprised of several speciality companies Azzur Consulting, a GxP compliance and consulting organization dedicated to helping life sciences companies succeed. Our experienced staff specializes in manufacturing systems & equipment design, installation & startup, commissioning, and verification/qualification, computerized systems validation, process validation, project management and related functions. Azzur Consulting also offers GxP compliance and audit services related to regulatory inspection prep and inspectional finding remediation as well as general project management support. We are continuously updating and maintaining our knowledge base with the latest regulatory requirements, industry best practices, and inspectional trends to help our clients stay ahead.
Our team is a network of skilled problem solvers with broad experience across biotechnology, pharmaceuticals and medical device businesses. Our goal is to keep our clients at the top of their industry. After all, our success is determined by the success of our clients.
Mon, 26 Jun 2017 11:16:36 PDT