Mihaela Florea Email and Phone Number

-Maintain marketing authorisation across a global product portfolio.-Manage CMC documentation for new registrations in Global and EU markets.-Advise on regulatory requirements and develop regulatory strategies -Compiling Module 3 documentation and submission for purely national and MRP procedures-Responsible of post licensing CMC activities with regard to Renewals, Variations-Answering questions raised by regulatory agencies during new registration procedures and… Show more -Maintain marketing authorisation across a global product portfolio.-Manage CMC documentation for new registrations in Global and EU markets.-Advise on regulatory requirements and develop regulatory strategies -Compiling Module 3 documentation and submission for purely national and MRP procedures-Responsible of post licensing CMC activities with regard to Renewals, Variations-Answering questions raised by regulatory agencies during new registration procedures and variations-Develop high quality working relations with other departments, agents, external consultants during the outcome of regulatory processes-Implementing approved leaflets and labels at local manufacturing site-Assessing local and global changes in a Change control system management (approve and follow-up until close-out change controls). Show less

-Life-Cycle-Management for pharmaceutical products : preparation, compilation, review and submission of the necessary documentation for different regulatory activities (variations type IA, IB, II, renewals, new registrations) via DCP, MRP and purely national registrations -Sustaining a good communication with Health Authorities with regard to regulatory activities; communicating with other departments, agents, external consultants during the outcome of regulatory processes- Maintenance… Show more -Life-Cycle-Management for pharmaceutical products : preparation, compilation, review and submission of the necessary documentation for different regulatory activities (variations type IA, IB, II, renewals, new registrations) via DCP, MRP and purely national registrations -Sustaining a good communication with Health Authorities with regard to regulatory activities; communicating with other departments, agents, external consultants during the outcome of regulatory processes- Maintenance activities of products master registration files; preparation of responses to deficiency letters received from Health Authorities -eCTD sequences compilation for regulatory activities-Data bases maintenance in a format consistent with internal and external standards and requirements Show less