28 Апр 2018
We are looking for a Registration Specialist
University Degree in Medicine or Pharmacy;
3+ years of related experience;
Profound knowledge of Ukrainian legislation/guidelines pertaining to Marketing Authorization of medicinal products and maintenance of product during its lifecycle;
Proven knowledge of Regulatory Affairs procedures for Marketing Authorization/renewal/variations;
Good knowledge of English (at least Intermediate level).
Gathering, evaluation and preparation of regulatory documents for submission (SPC, Instruction for Medical Use, Methods of Quality Control, packaging etc);
Preparation and delivery of regulatory submissions (registration, renewal, variations) and procedure proceeding until it final approval;
Responsible for products packaging compliance review with further validation for production and submission of the mock-ups to the Regulatory Authorities;
Participation in the process of GMP recognition of Company’s manufacturing sites in Ukraine;
Assessing of regulatory requirements and developing regulatory strategies to obtain timely regulatory approvals.
Official full-time employment;
28 days of yearly vacation;
Life and medical insurance;
Compensation of lunches.
If you feel that all the mentioned above is about you and you are ready to take up the challenge with us, come to join our professional team in Servier!
Send your CV to ОТПРАВИТЬ РЕЗЮМЕ