Senior Scientist, Regulatory Affairs - CMC

Provide input to global product and project regulatory strategies by performing assessments of CMC changes Execute regulatory strategies by leading the development, authoring and review of CMC submission components Liaise with global CMC, Manufacturing Division and external partners Assess and communicate potential regulatory risks and propose mitigation strategies Deliver all regulatory milestones for assigned products across the product lifecycle Requirements Bachelor’s in Science, Engineering, or a related field (advanced degree preferred but not required) up to 5 years Pharmaceutical industry experience or up to 2 years experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics Adaptability Biopharmaceutical Industry Change Management Detail-Oriented Document Coordination Electronic Common Technical Document (eCTD) Interpersonal Relationships Pharmaceutical Manufacturing Regulatory CMC Writing Technical Documents Core Competencies Demonstrates expertise in Regulatory CMC processes, including the development and submission of CMC components for small molecules, vaccines, and biologics. Proficient in managing regulatory milestones and assessing potential risks while ensuring compliance within the biopharmaceutical industry. Highest-signal resume keywords Regulatory CMC CMC Submission Management Electronic Common Technical Document (eCTD) Pharmaceutical Industry Experience Writing Technical Documents Hard Skills CMC Submission Management Regulatory CMC Writing Technical Documents Document Coordination Change Management Soft Skills Detail-Oriented Adaptability Interpersonal Relationships Industry Keywords Biopharmaceutical Industry Pharmaceutical Manufacturing Tools & Technologies Electronic Common Technical Document (eCTD) #J-18808-Ljbffr Jobtailor