We are seeking an EMA reporting associate to ensure compliance with European Medical Agency requirements for centrally registered products.
Job Description
This role involves monitoring daily stock levels for a portfolio of centrally registered products through regular communication with markets in Western and Eastern Europe. The goal is to consolidate and track all reported cases of out-of-stock situations across European markets, working closely with colleagues in Central Planning, Regulatory, and QA departments to provide written feedback to EMA on stock levels, supply shortages, projected supply resumptions, and demand-supply analytics.
The position requires participating in calls and online sessions organized by EMA during supply shortage tensions, escalating internal alerts when necessary. Additionally, the associate will declare stock levels, confirmed shortages, and supply risks on EMA online portals accurately and on time, supporting the preparation of analytics and reports for impacted portfolios and providing updates to EMA as needed.
Key Responsibilities
* Monitor daily stock levels and communicate with markets in Western and Eastern Europe.
* Consolidate and track all reported cases of out-of-stock situations across European markets.
* Liaise with Central Planning, Regulatory, and QA colleagues to provide written feedback to EMA.
* Participate in calls and online sessions organized by EMA during supply shortage tensions.
* Declare stock levels, confirmed shortages, and supply risks on EMA online portals.
Benefits
This position contributes to STADA's commitment to operational excellence and regulatory compliance. The successful candidate will be part of a proactive approach to regulatory and supply challenges.
About the Role
This is an essential role that requires a strong understanding of EMA regulations and the ability to work effectively in a team environment. The ideal candidate will have excellent communication and analytical skills, with the ability to manage multiple tasks and prioritize deadlines.