Regulatory Site Office Manager Vaccines - Sanofi : Job Details

Lead regulatory compliance for assigned vaccine products at Swiftwater site, including change control assessments and supplier change notifications. Author and manage CMC regulatory documentation for global marketing authorizations, site registrations, and annual reports. Ensure regulatory compliance for batch release processes and maintain product license requirements across multiple markets. Prepare and coordinate responses to Health Authority questions, working with site experts and regulatory affiliates. Serve as regulatory expert on Manufacturing & Supply project teams, providing strategic guidance on regulatory requirements and impact assessments. Support site inspection readiness and participate in Health Authority audits/inspections. Review and approve critical site documentation including SOPs, technical reports, and Site Master File updates. Coordinate with global Regulatory Affairs teams to ensure alignment of CMC strategies and timely completion of regulatory submissions. D...Office Manager, Regulatory, Manager, Office, Regulatory Affairs, Business Services