Senior Manager, Regulatory Operations
Core
Lead global regulatory submissions, regulatory information management, and publishing operations for a clinical-stage biopharmaceutical company developing alpha-helical peptide medicines.
Role type
Senior Manager/Associate Director, Regulatory Operations
Builds
Global regulatory submissions, inspection-ready regulatory information, and scalable internal publishing processes.
Domain
Biopharmaceuticals / Clinical Development / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory Operations leadership, Veeva RIM Basics, eCTD publishing, FDA electronic submissions, global submission lifecycle management, SOP development, project management
Preferred skills
AI tool utilization for daily operations
Technologies
Veeva Vault RIM, Veeva RIM Basics
Responsibilities
Provide operational leadership for global regulatory submissions from planning to archival; Serve as business lead for Regulatory Information Management; Partner with stakeholders to implement standardized document lifecycle management; Support transition to internal Regulatory Operations publishing model; Develop and maintain inspection-ready regulatory information; Partner with Director to modernize operations through technology and automation
Seniority
Senior Manager/Associate Director, hands-on IC with strategic oversight