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| Associate Director MA Open (J#39411) Title: Associate Director Company: Arbita Salary: Open Job Description This position is in the Regulatory CMC group and is focused on the development of small molecules, specifically, BG-12 and other late stage programs. Responsibilities include actively contributing to the development and implementation of CMC regulatory strategy for specific small molecule projects including identifying and assessing regulatory risks, implementing NDA/MAA filing readiness strategy, developing pre-NDA/MAA agency meeting strategies, serving as the regulatory representative on project teams, serving as the regulatory contact with relevant regulatory authorities, and coordinating all CMC aspects of regulatory submissions.yyy Minimum 8 years pharmaceutical/biotechnology industry experience, 4 years regulatory experience working on small molecule programs. yyy Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals. yyy Demonstrate excellent communication skills. yyy Ability to represent the department in project teams. More... | |||
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