Iva Miskulin

1. Fulfilment of all regulatory requirements in the territory of Croatia, HA interaction
2. Responsible for coordination and running of EU procedures
3. eCTD publishing and document management system
4. Close cooperation with marketing department, providing regulatory scenarios,
timelines, trend and intelligence information
5. Accountability for compliance with SOPs and legislation and ensuring that product's
quality requirements are fulfilled
6. Responsibility for maintaining Marketing Authorizations of assigned products in
accordance with SOPs and legislation (renewals; variations; extension of
registrations)
7. Ensurement that local labelling of products complies with valid global product
labelling and the local legislation
8. Ownership and maintenance of dossiers and other technical files
9. Close cooperation with regional and local logistic department and LQR / QA
Manager
10. Ensurement of local input into RA databases and responsibility for data
compliance
11. Member of pharma initiatives and association