Regulatory Affairs Professional Tarrytown NY Apply
Description:
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 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 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.
