Regulatory Affairs Senior Specialist, Regional CoE
Core
Manage operational delivery of Life Cycle Management (LCM) regulatory activities, including dossier preparation, Health Authority query management, and post-approval change implementation for assigned markets.
Role type
Senior Regulatory Affairs Specialist (Regional Centre of Excellence)
Builds
High-quality regulatory submission packages and maintains product licenses across multiple markets
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Regulatory affairs experience, dossier preparation, Health Authority query management, post-approval change implementation, project coordination, regulatory systems maintenance, regulatory intelligence, translation coordination
Preferred skills
Veeva RIM/ERV experience, digital workflow initiatives, automation programs
Technologies
Veeva RIM, ERV
Responsibilities
Plan and execute LCM activities; compile and customize submission dossiers; coordinate CMC and non-CMC content; execute dossier submissions; manage Health Authority queries; track approvals and implement variations; manage labeling; maintain regulatory systems; provide status reporting and risk management.
Seniority
Senior, hands-on IC