Regulatory Compliance Specialist
This role requires a professional to ensure compliance with European Medical Agency (EMA) reporting requirements for centrally registered products. The specialist will monitor stock levels across European markets, manage critical supply shortage communications, and support regulatory obligations.
The position involves liaising with colleagues from Central Planning, Regulatory, and QA departments to provide written feedback to EMA on stock levels, supply shortages, projected supply resumptions, and demand-supply analytics. Participation in calls and online sessions organized by EMA during supply shortage tensions is also required. Additionally, the specialist will declare stock levels, confirmed shortages, and supply risks on EMA online portals accurately and on time.
The specialist will support the preparation of analytics and reports for impacted portfolios and provide updates to EMA as needed. They will consolidate information required for EMA's Supply Shortage Prevention Pilot project and contribute to other projects initiated to meet EMA requirements.
Responsibilities:
* Ensure compliance with EMA reporting requirements for centrally registered products.
* Monitor stock levels across European markets and manage critical supply shortage communications.
* Support regulatory obligations and liaise with colleagues from Central Planning, Regulatory, and QA departments.
* 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 accurately and on time.
* Support the preparation of analytics and reports for impacted portfolios.
* Consolidate information required for EMA's Supply Shortage Prevention Pilot project.
Requirements:
* Degree from an Engineering or Business School with a focus on supply chain management or logistics.
* At least 3 years of professional experience in supply chain, regulatory, or a similar role, ideally within the pharmaceutical industry.
* Strong proficiency in Advanced Excel and provable experience with SAP; knowledge of regulatory reporting tools is an advantage.
* Excellent communication skills in English at an upper-intermediate level; knowledge of German is also preferred.