Pharmaceuticals Bioequivalence Expert

2 weeks ago


Fatih, Istanbul, Turkey Bilim İlaç Full time

At Bilim Pharmaceuticals, we are seeking a highly skilled Bioequivalence Specialist to join our CMC Management team. This is an exciting opportunity for individuals who are passionate about advancing the field of pharmaceuticals.

About the Role
  • As a Bioequivalence Specialist, you will play a critical role in conducting bioequivalence and bioavailability studies for human pharmaceuticals.
  • Your primary responsibilities will include researching reference products, designing study protocols, and coordinating with Contract Research Organisations (CROs).
  • You will also be responsible for preparing investigational medicinal products, following regulatory guidelines, and ensuring timely completion of studies.

We are looking for candidates with a strong background in pharmacy, chemistry, or a related field, and at least 2 years of experience in bioequivalence, bioavailability studies, or clinical trials in the pharmaceutical industry.

Key Responsibilities
  1. To conduct literature researches on biowaiver writings and prepare reports.
  2. To prepare answers to Clinical, Bioequivalence/Bioavailability, Biowaiver questions from the Ministry of Health and Authorities in line with EMA/FDA/ICH/TITCK requirements.
  3. To evaluate change controls within the scope of Bioequivalence/Bioavailability studies and take necessary actions.

If you are a motivated and detail-oriented individual who is passionate about advancing the field of pharmaceuticals, we encourage you to apply for this exciting opportunity.



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