26 Июн 2018
The representative office of the European Pharmaceutical Company Antibiotice announces a competition for filling the vacant position of the:
REGULATORY AFFAIRS SPECIALIST FOR REGISTRATION OF
· Higher education (medical, pharmaceutical);
· Knowledge of the current legislation of Ukraine and regulatory documents in the field of drug registration and GMP confirmation;
· Work experience in similar position for at least 2 years;
· Knowledge of English is not lower than intermediate;
· Computer skills;
· Dynamic, proactive and self-motivated, with high communication skills (both written and spoken), well organized, able to work with confidential information, excellent attention to detail and accuracy.
· Compiles and reviews of a registration/re-authorization dossier;
· Maintains compliance with regulatory requirements for generic drugs for the UA market.
· Maintains Regulatory Databases;
· Maintains procedures for registration and re-registration of medicinal products, introduction of changes in registration documents during the term of the RS;
· Monitoring of changes in legislation in the field of registration of medicinal products and compliance with the requirements of authorized regulatory bodies;
· Interaction with authorized state bodies to ensure proper registration of drugs;
· Implementation of GMP certificate validation procedure for production sites;
· Supports tender requirements with appropriate regulatory information.
Salary based on interview results.
Send your CV to e-mail: ОТПРАВИТЬ РЕЗЮМЕ
For details you can call at phone numbers: +380 (XX) XXX-XX-XX Показать
In the summary, please indicate the level of the desired salary.