Regulatory Affairs Manager
The role is mainly focused on the regulatory management of products all over the world, in strict cooperation with the International Pharma Sales Team and with the International Regulatory Affairs team. The role is responsible for over 1000 marketing authorizations in over 100 Countries. The role is based in Cork and reports directly to the VP, International Pharma Sales and functionally to the Group Regulatory Affairs
- Ensures that International Sales team can optimize the footprint of products by ensuring timely coordination of regulatory activities, Regulatory Authorities and/or relevant third parties in the countries; In coordination with export managers and HQ Regulatory, defines international regulatory strategy considering the effective situation of our dossiers and the commercial plans of the International Sales division.
- In cooperation with the HQ regulatory team, and according to the HQ plans, is involved in the worldwide regulatory management of the marketing authorizations. This includes:
- Management and appropriate archiving of official approval documents and correspondence from the Regulatory Authorities for all products where Ireland is the Marketing Authorization Holder;
- Responsible for creating and maintaining a yearly roadmap to help prioritization of regulatory activities for International and Ireland.
- Acts as regulatory contact point for the export managers;
- In case of new licensing contracts that require regulatory activities, takes care of the appropriate drafting and signature of the regulatory agreements with partners and agrees on the regulatory action plan with the HQ team;
- Collaborate with HQ regulatory team on the lifecycle management planning of Marketing Authorizations related to International Pharma Sales BU, focusing on registrations in Latin America, Asia-Pacific, Africa, Middle East;
- Updates Regulatory Status for registered products (e.g. Marketing Status, Transfer of Ownership) related to International Pharma Sales BU;
- BSc in relevant areas with 5 + years relevant experience
- Knowledge, at least in a general way, of pharmaceutical regulations applicable in Europe, Latin America, Asia, Pacific, Middle east
- Project management
- Knowledge of the CTD dossier and product information
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