at VIVA USA Inc. in Newark, Delaware, United States
Analyzes the requirements and prepares product related regulatory submissions.
Creates quality guidelines and work instructions relevant for maintaining regulatory compliance.
Identifies, analyzes and implements country specific requirements necessary for product related submissions
Plans and prepares product related submissions with the client internal (e.g. Regional Units) or external organizations according to regulatory requirements.
Performs regulatory projects or acts as a member of the project steering group.
Submits required documentation/information to local authorities or client internal.
Initiates and escalates necessary activities if deviations are identified.
Ensures creation of adequate documentation for audits/inspections.
Performs training within the organization in country specific regulatory requirements, if applicable.
Performs review of promotional material for regulatory compliance according to country specific requirements.
May represent the company in industry associations (Lobbying), if applicable. "Transfers"Is expected to integrate processes and results from other workflows and disciplines to develop and accountably propose appropriate and effective solutions. 5-8 years Deep professional know-how and experience in one Sub Job Family. Masters domain and transfers and applies know-how to/in various contexts.
Solid professional judgment and problem solving competence.
Improves existing processes and approaches.