CMC Regulatory Specialist

A company is looking for a CMC Regulatory Specialist to manage documentation activities for regulatory submissions related to cell therapy brands.Key ResponsibilitiesManage document preparation for CMC regulatory submission documents to ensure compliance with formatting requirementsCoordinate reviews and facilitate consensus meetings within the authoring system for CMC regulatory submissionsParticipate in cross-functional project teams and interact with technical subject matter experts and regulatory partnersRequired QualificationsBachelor's degree in a relevant discipline with 4-7 years of relevant experience, or a Master's degree with 1-3 years of relevant experienceWorking knowledge of regulatory CMC submissions, with experience in Cell Therapy being a plusAbility to work independently and collaboratively in a team environmentExcellent time management and organizational skillsFlexibility to manage multiple projects in a fast-paced environment