Senior Manager Regulatory Affairs

Responsibilities Responsible for on-time filing of high-quality regulatory submissions Preparation and review of ANDAs, NDAs, annual reports, periodic adverse events reports, supplements, amendments Reviews and manages regulatory submissions to FDA from international partners and CMOs Review and approve CMC and labeling change controls Familiar with FDA requirements and ICH Adhere to submission timelines Administration and management of assigned products Serve as the primary regulatory interface with US FDA manufacturing partners and internal teams Support biosimilar BLA/PAS/CBE submissions Requirements Bachelor’s degree in life sciences preferred, or equivalent experience required 5 or more years of recent pharma / biotech / life sciences industry experience in a related function (Regulatory Affairs, R&D, Quality, Manufacturing) preferred Strong written and communication skills Ability to handle multiple projects concurrently Familiar with 21 CFR, FDA and ICH MS Office proficiency (Excel, Word, PowerPoint) #J-18808-Ljbffr