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Job #03109

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 CMC Manager, Regulatory Affairs Los Angeles, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Contribute to the development and implementation of regulatory strategy for specific projects by identifying and assessing regulatory risks 2) Coordinate all aspects of regulatory submissions with a focus on CMC 3) Plan, write, coordinate and review CMC documentation/data to support regulatory submission activities for IND/CTA and NDA/MAAs (including IMPD Quality Section) and amendments/supplements/variations 4) Ensure the quality and content of all CMC submissions to global health authorities 5) Contribute to the development of comparability, validation and stability protocols for global regulatory compliance 6) Ensure adherence to global regulatory requirements Requirements 1) BS in Chemistry or a related Science (Biochemistry, Biology, Pharmacy, Microbiology) 2) Minimum 3 – 5 years of regulatory experience with an emphasis on CMC strategy and submissions (biotech/pharmaceutical industry) 3) Minimum 3 – 5 years of supervisory/management experience 4) Experience in and knowledge of relevant US and EU regulations/directives and guidance (including ICH guidance) 5) Familiarity with the overall drug development process and regulatory CMC expectation throughout all development phases a plus 6) Proficiency in MS Word and electronic document management systems 7) Knowledge of CTD and eCTD application requirements and processes 8) Excellent communication skills (written and oral)