Associate I, Regulatory Operations
Core
Handling operational back-office aspects of regulatory submissions, including dossier preparation, submission management, publishing, licensing, and labeling for global eye health products.
Role type
Associate I, Regulatory Operations (Professional Path)
Builds
Regulatory dossiers, submission records, and compliance documentation for Alcon's product franchises.
Domain
Healthcare / Ophthalmology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Dossier preparation, submission management, database maintenance, regulatory compliance monitoring, SOP adherence, documentation management, regulatory interpretation, audit implementation, cross-functional guidance.
Preferred skills
None stated
Technologies
None stated
Responsibilities
Prepare dossiers and manage submissions for all franchises; maintain Regulatory Affairs Archives and Tech File Administration; file product notifications and approval applications with government agencies; interpret proposed regulations and advise management; implement and audit compliance processes; provide guidance to development and marketing teams on product changes and labeling.
Seniority
Entry-level Associate
