Job expirat
This position is responsible for managing regulatory support to market the products.
The occupant will be responsible for developing regulatory submission strategies, registration dossiers and managing departmental projects, supervising development of or creating and reviewing labeling, providing guidance and consultation for Romania, EU and international regulations, interacting with regulatory agencies and certification bodies .
Main responsabilities
-Submit such registration files to local competent authorities (ANM), by National, MRP or DCP route.
-Supervise all the translations related to documents/dossiers sent by the Group and which have to be submitted to any local authorities/entities within the scope of regulatory projects (e.g. SmPC, labeling and Patient Leaflet, etc);
-Maintain records of current registration dossiers and the status of procedures;
-Liaise with Regulatory Affairs and Corporate groups on regulatory issues
-Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
Skills/Experience
-Life sciences degree
-3 – 5 years experience in Regulatory Affairs within the Pharmaceutical industry
-Knowledge of the National and EU regulatory framework
-Languages: Very good written and oral communications skills in English , Italian will be a plus.
Infomed fluids S.R.L. is a company from Romania based on developind and making perfusabil solutions in pvc bags and bottled. Member of the Italian ACS Dobfal group
If you are interested in this job please send your job application at:
- resurseumane@infomedfluids.ro;
-fax number: 021 345 31 85 or directly to Theodore Pallady Boulevards, no. 50, District 3, Bucharest
