To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03108

About our client Our client is a publicly traded biotechnology company headquartered in Los Angeles that focuses on the development and commercialization of various oncology therapeutics. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Director of Regulatory Affairs Los Angeles, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide US regulatory stewardship for the assigned development candidate(s) 2) Serve as the company's regulatory liaison with FDA Division staff accountable for the assigned product(s) 3) Develop US regulatory strategy in support of the Global Regulatory Plan 4) Provide US regulatory intelligence assessments in support of assigned therapeutic area 5) Contribute to development of IND/NDA original documents and amendments intended for submission to FDA 6) Ensure compliance with US regulatory strategies and requirements 7) Manage FDA meetings for assigned product including development of required documentation 8) Collaborate with the Global Regulatory Team and Clinical Study Team for assigned project Requirements 1) Pharm. D or Bachelor’s degree in a Life Science-related field (advanced degree preferred) 2) Minimum 5 years of experience in the US pharmaceutical industry (RA management) 3) Proven success in submissions/management of INDs/NDAs/BLAs 4) In-depth knowledge of US FDA regulations and guidelines including ICH 5) Good planning and strategic skills 6) Excellent leadership, communication and organizational skills