Country Manager, Ireland

1. Local Liaison & Operational Management o Act as the primary liaison in Ireland and Europe, coordinating communication between internal stakeholders (headquarters, functional teams) and external parties (regulatory authorities, service providers, partners) to ensure efficient response to business needs. o Oversee daily operations of the Irish entity, including compliance management, document archiving, administrative support, and collaboration with local legal and finance teams. o Manage the company’s registered address, office facilities, and relationships with local vendors (e.g., logistics, IT support).

2. Quality Assurance (QA) & Pharmacovigilance (PV) Support o Assist in supervising outsourced service providers for QA/PV-related activities to ensure compliance with EU and Irish regulatory requirements. o Coordinate the maintenance and updates of quality system documentation, supporting Commercial QP (Qualified Person) and IMP (Investigational Medicinal Product) activities. o Participate in the collection and submission of drug safety reports, facilitating the implementation of EU QPPV (Qualified Person for Pharmacovigilance) and national liaison responsibilities. o Track and manage budgets for outsourced services, driving the gradual internalization of transactional tasks.

3. Regulatory & Compliance Affairs o Ensure compliance with EU MAH (Marketing Authorization Holder) regulations, including obligations to EMA (European Medicines Agency) and MHRA (UK Medicines and Healthcare products Regulatory Agency). o Support local regulatory submissions (e.g., product defect reporting, recall management) and act as the emergency contact for regulatory inquiries. o Assist in maintaining legal entity-related matters for the Irish company, including collaboration with the Nominee Director and management of legal documents.