Nivel cariera

Middle (2-5 ani), Senior (5-10 ani), Entry (0-2 ani)

Limbi vorbite

engleză

Adresa/ adresele jobului

București


Job description (main tasks):

  • Collects information from Regulatory Affairs within Alvogen regarding the local requirements for additional Comparative Dissolution Profiles (CDPs);
  • Identifies the need of additional CDPs with regards to the local requirements;
  • Checks acceptance of the available Bioequivalence (BE) study(ies) - collect the complete details of the local reference product(s);
  • Checks if additional testing is required – predominantly CDPs – in order to use the available BE study(ies);
  • Coordinates the performing of any necessary additional CDPs, including for submission of biowaivers, as per the local requirements;
  • Coordinates products samples delivery for additional Comparative Dissolution Profiles (CDPs), if needed;
  • Coordinates selection of test and reference products’ batch, as needed;
  • Review final reports of additionally conducted CDPs;

Candidate Requirements:

  • University/college degree in Chemistry, Biology, Biochemistry, Pharmacy, Life Science;
  • Minimum 2 years of relevant experience;
  • Strong knowledge of requirements for Comparative Dissolution Profiles (CDPs); strong knowledge of applicable research regulatory requirements;
  • Ability to work effectively without direct supervision and to be able to report succinctly and efficiently;
  • Fluent written and spoken English;
  • Excellent computer skills including MS Office applications;
  • Good communication skills;
  • Attention to details;
  • Analytical thinking, problem solving capacity;
  • Well organized;