What are the responsibilities and job description for the Senior Manager, CMC Regulatory Affairs position at Novavax?
A company is looking for a Senior Manager, Global Regulatory Affairs - CMC.Key ResponsibilitiesAssist with CMC regulatory submission strategies and manage key regulatory CMC activitiesCommunicate and coordinate with functional groups to prepare required CMC documentation for regulatory submissionsAct as regulatory CMC representative on project teams, ensuring compliance with regulatory requirementsRequired Qualifications, Training, and EducationBachelor's degree in a scientific field; advanced degree is desirable6-10 years of experience in the biotechnology industry, with 4-5 years in Regulatory Affairs CMCBackground in vaccine development and knowledge of the vaccine drug product development processExperience with aseptically filled drug products and current GMPsFamiliarity with CTD format and content
