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 the 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.
"Expands"Needs to consider processes and results, generated in other workflows and disciplines, implies conditions and environments, and values significance to contribute effectively to team results.
Needs experienced level of analytical and distinctive conceptual skills to solve issues given, which may differ in size and nature.
3-5 years Thorough professional know-how in one
Sub Job Family, based on practical experience and theoretical foundation.
Focus on applying and expanding acquired knowledge base. Application of knowledge in broader professional context.