Senior Regulatory Affairs Specialist, Regional CoE
Core
Manages operational delivery of Lifecycle Management (LCM) activities for assigned countries or clusters, including dossier preparation, submission coordination, and Health Authority query management.
Role type
Senior Regulatory Affairs Specialist (Established Products)
Builds
Country-ready regulatory submission packages and maintains product licenses
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
Dossier preparation, submission coordination, Health Authority query management, CMC/non-CMC content coordination, regulatory data maintenance, labeling compliance, project coordination, problem-solving, written communication
Preferred skills
Veeva RIM/ERV proficiency, digital workflow automation, experience with multiple markets/clusters, continuous improvement initiatives
Technologies
Veeva RIM, ERV, regulatory intelligence platforms
Responsibilities
Plan and deliver assigned product LCM activities; Prepare and customize submission dossiers; Coordinate CMC and non-CMC content with international teams; Execute or support timely submissions; Track assessment and coordinate responses to Health Authority questions; Obtain and track LCM approvals and implement variations; Coordinate labeling customization and compliance checks; Maintain regulatory system records; Provide status reporting and risk escalation.
Seniority
Senior, hands-on IC