Job description / Role
Their Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organised compliance partnering with external regulatory agencies. They are on the leading-edge of health care breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
For assigned products and tasks, stays updated on relevant regional and local regulations and guidelines.
Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
By discretion of Regulatory Affairs Management and due to organisation and work load, all listed activities need not to be performed.
Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
Ensures Electronic Medicines Compendium submissions, approvals and record keeping.
Participates in internal EEMEA regulatory work groups on selected issues.